{
    "info": {
        "nct_id": "NCT00976131",
        "official_title": "Phase I Randomized, Placebo-Controlled, Cross-Over, Dose-Finding Pharmacokinetic Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer",
        "inclusion_criteria": "* Diagnosis of early stage breast cancer (stage I, II, or III);\n* Scheduled to receive at least four rounds of dose dense doxorubicin therapy in the neoadjuvant or adjuvant setting;\n* No other history of prior chemotherapy, radiation, or hormonal therapy in the previous 5 years;\n* For women receiving adjuvant therapy, single lumen implanted venous access device (i.e. single port) for unilateral cancer and double lumen implanted venous access device (i.e. double port) for bilateral breast cancer\n* Age 21 years or older;\n* ECOG performance status ≤ 2 (Karnofsky > 60%);\n* Normal organ and marrow function defined as: Leukocytes ≥ 3,000/uL, Absolute neutrophils count (ANC) ≥ 1,500/uL at baseline, Platelets ≥ 100,000/uL, Total bilirubin ≤ 1.5 X normal institutional limits, AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional ULN, Serum creatinine within normal institutional limits;\n* Left ventricular ejection fraction > 55%;\n* No history of CoQ10 supplement use within 30 days of initiating study drug;\n* No uncontrolled or significant co-morbid illness;\n* Not pregnant, not breastfeeding, and not planning on becoming pregnant during the course of the study;\n* Willingness to comply with all study intervention and follow-up procedures;\n* Ability to speak English or Spanish; and\n* Ability to provide informed consent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 21 Years",
        "exclusion_criteria": "* Inability to understand or an unwillingness to sign a written informed consent document;\n* Any significant toxic side effects related to first or second dose of doxorubicin/cyclophosphamide chemotherapy or biologic therapy that did not resolve to less than a CTCAE 3.0 grade 3 non-hematological toxicity;\n* Currently using any investigational agent;\n* Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with the participant's ability to follow the protocol or achieve study objectives;\n* Psychological or sociological conditions, addictive disorders, or family problems that would preclude adherence with study drug or compliance with the protocol\n* Women who report pregnancy, are breast feeding, or have a positive pregnancy test;\n* Use of CoQ10 supplement use within 30 days of initiating study drug;\n* Use of over-the-counter nutritional vitamin greater than 5x RDA;\n* Fish allergy (due to fish-based softgel shell);\n* Currently taking FDA cardioprotective drugs, such as Zinecard (dexrazoxane);\n* History of chronic hepatitis B, hepatitis C, and HIV infection;\n* Problems swallowing oral medications due to prolonged emesis, mucositis, esophageal dysfunction, etc.; and,\n* Currently taking any form of antioxidant supplements while on study.\n* Use of warfarin.\n* Kosher (due to fish-based softgel shell)\n* Dietary restriction of tilapia (due to tilapia fish-based softgel shell)\n* Titanium Dioxide allergy (due to the opaque coloring used in the softgel).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Diagnosis of early stage breast cancer (stage I, II, or III);",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of early stage breast cancer",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II",
                                "III"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Scheduled to receive at least four rounds of dose dense doxorubicin therapy in the neoadjuvant or adjuvant setting;",
            "criterions": [
                {
                    "exact_snippets": "Scheduled to receive at least four rounds of dose dense doxorubicin therapy",
                    "criterion": "doxorubicin therapy",
                    "requirements": [
                        {
                            "requirement_type": "schedule",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "rounds",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "rounds"
                            }
                        },
                        {
                            "requirement_type": "dose density",
                            "expected_value": "dose dense"
                        }
                    ]
                },
                {
                    "exact_snippets": "in the neoadjuvant or adjuvant setting",
                    "criterion": "treatment setting",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "neoadjuvant",
                                "adjuvant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other history of prior chemotherapy, radiation, or hormonal therapy in the previous 5 years;",
            "criterions": [
                {
                    "exact_snippets": "No other history of prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other history of prior ... radiation",
                    "criterion": "prior radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other history of prior ... hormonal therapy",
                    "criterion": "prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For women receiving adjuvant therapy, single lumen implanted venous access device (i.e. single port) for unilateral cancer and double lumen implanted venous access device (i.e. double port) for bilateral breast cancer",
            "criterions": [
                {
                    "exact_snippets": "For women receiving adjuvant therapy, single lumen implanted venous access device (i.e. single port) for unilateral cancer",
                    "criterion": "venous access device",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "single lumen"
                        },
                        {
                            "requirement_type": "indication",
                            "expected_value": "unilateral cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "For women receiving adjuvant therapy, ... double lumen implanted venous access device (i.e. double port) for bilateral breast cancer",
                    "criterion": "venous access device",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "double lumen"
                        },
                        {
                            "requirement_type": "indication",
                            "expected_value": "bilateral breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 21 years or older;",
            "criterions": [
                {
                    "exact_snippets": "Age 21 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status ≤ 2 (Karnofsky > 60%);",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky > 60%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal organ and marrow function defined as: Leukocytes ≥ 3,000/uL, Absolute neutrophils count (ANC) ≥ 1,500/uL at baseline, Platelets ≥ 100,000/uL, Total bilirubin ≤ 1.5 X normal institutional limits, AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional ULN, Serum creatinine within normal institutional limits;",
            "criterions": [
                {
                    "exact_snippets": "Leukocytes ≥ 3,000/uL",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "uL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Absolute neutrophils count (ANC) ≥ 1,500/uL",
                    "criterion": "absolute neutrophils count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "uL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets ≥ 100,000/uL",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "uL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total bilirubin ≤ 1.5 X normal institutional limits",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X normal institutional limits"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional ULN",
                    "criterion": "AST (SGOT)/ALT (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum creatinine within normal institutional limits",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "within normal institutional limits"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Left ventricular ejection fraction > 55%;",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction > 55%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of CoQ10 supplement use within 30 days of initiating study drug;",
            "criterions": [
                {
                    "exact_snippets": "No history of CoQ10 supplement use within 30 days",
                    "criterion": "CoQ10 supplement use",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled or significant co-morbid illness;",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled or significant co-morbid illness",
                    "criterion": "co-morbid illness",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "significance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not pregnant, not breastfeeding, and not planning on becoming pregnant during the course of the study;",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not planning on becoming pregnant during the course of the study",
                    "criterion": "pregnancy plans",
                    "requirements": [
                        {
                            "requirement_type": "plans during study",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willingness to comply with all study intervention and follow-up procedures;",
            "criterions": [
                {
                    "exact_snippets": "Willingness to comply with all study intervention and follow-up procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to speak English or Spanish; and",
            "criterions": [
                {
                    "exact_snippets": "Ability to speak English or Spanish",
                    "criterion": "language ability",
                    "requirements": [
                        {
                            "requirement_type": "languages",
                            "expected_value": [
                                "English",
                                "Spanish"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Ability to provide informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 21 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Inability to understand or an unwillingness to sign a written informed consent document;",
            "criterions": [
                {
                    "exact_snippets": "Inability to understand",
                    "criterion": "understanding ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwillingness to sign a written informed consent document",
                    "criterion": "willingness to sign consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any significant toxic side effects related to first or second dose of doxorubicin/cyclophosphamide chemotherapy or biologic therapy that did not resolve to less than a CTCAE 3.0 grade 3 non-hematological toxicity;",
            "criterions": [
                {
                    "exact_snippets": "significant toxic side effects related to first or second dose of doxorubicin/cyclophosphamide chemotherapy or biologic therapy",
                    "criterion": "toxic side effects",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "related to",
                            "expected_value": [
                                "doxorubicin",
                                "cyclophosphamide",
                                "biologic therapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "did not resolve to less than a CTCAE 3.0 grade 3 non-hematological toxicity",
                    "criterion": "resolution of toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "CTCAE 3.0 grade"
                            }
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "non-hematological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently using any investigational agent;",
            "criterions": [
                {
                    "exact_snippets": "Currently using any investigational agent",
                    "criterion": "use of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with the participant's ability to follow the protocol or achieve study objectives;",
            "criterions": [
                {
                    "exact_snippets": "Unstable or severe intercurrent medical condition",
                    "criterion": "intercurrent medical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "unstable",
                                "severe"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in the opinion of the investigator, might interfere with the participant's ability to follow the protocol or achieve study objectives",
                    "criterion": "interference with protocol adherence",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "investigator"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Psychological or sociological conditions, addictive disorders, or family problems that would preclude adherence with study drug or compliance with the protocol",
            "criterions": [
                {
                    "exact_snippets": "Psychological or sociological conditions ... that would preclude adherence with study drug or compliance with the protocol",
                    "criterion": "psychological or sociological conditions",
                    "requirements": [
                        {
                            "requirement_type": "impact on adherence",
                            "expected_value": "preclude adherence with study drug or compliance with the protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "addictive disorders ... that would preclude adherence with study drug or compliance with the protocol",
                    "criterion": "addictive disorders",
                    "requirements": [
                        {
                            "requirement_type": "impact on adherence",
                            "expected_value": "preclude adherence with study drug or compliance with the protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "family problems ... that would preclude adherence with study drug or compliance with the protocol",
                    "criterion": "family problems",
                    "requirements": [
                        {
                            "requirement_type": "impact on adherence",
                            "expected_value": "preclude adherence with study drug or compliance with the protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who report pregnancy, are breast feeding, or have a positive pregnancy test;",
            "criterions": [
                {
                    "exact_snippets": "Women who report pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "reporting",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "are breast feeding",
                    "criterion": "breast feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have a positive pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of CoQ10 supplement use within 30 days of initiating study drug;",
            "criterions": [
                {
                    "exact_snippets": "Use of CoQ10 supplement use within 30 days of initiating study drug",
                    "criterion": "CoQ10 supplement use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of over-the-counter nutritional vitamin greater than 5x RDA;",
            "criterions": [
                {
                    "exact_snippets": "Use of over-the-counter nutritional vitamin greater than 5x RDA",
                    "criterion": "over-the-counter nutritional vitamin use",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "RDA"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fish allergy (due to fish-based softgel shell);",
            "criterions": [
                {
                    "exact_snippets": "Fish allergy",
                    "criterion": "fish allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently taking FDA cardioprotective drugs, such as Zinecard (dexrazoxane);",
            "criterions": [
                {
                    "exact_snippets": "Currently taking FDA cardioprotective drugs, such as Zinecard (dexrazoxane)",
                    "criterion": "FDA cardioprotective drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of chronic hepatitis B, hepatitis C, and HIV infection;",
            "criterions": [
                {
                    "exact_snippets": "History of chronic hepatitis B",
                    "criterion": "chronic hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of ... HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Problems swallowing oral medications due to prolonged emesis, mucositis, esophageal dysfunction, etc.; and,",
            "criterions": [
                {
                    "exact_snippets": "Problems swallowing oral medications due to prolonged emesis",
                    "criterion": "swallowing oral medications",
                    "requirements": [
                        {
                            "requirement_type": "difficulty",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prolonged emesis",
                    "criterion": "emesis",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "prolonged"
                        }
                    ]
                },
                {
                    "exact_snippets": "mucositis",
                    "criterion": "mucositis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "esophageal dysfunction",
                    "criterion": "esophageal dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently taking any form of antioxidant supplements while on study.",
            "criterions": [
                {
                    "exact_snippets": "Currently taking any form of antioxidant supplements",
                    "criterion": "antioxidant supplements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of warfarin.",
            "criterions": [
                {
                    "exact_snippets": "Use of warfarin.",
                    "criterion": "warfarin use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Kosher (due to fish-based softgel shell)",
            "criterions": [
                {
                    "exact_snippets": "Kosher (due to fish-based softgel shell)",
                    "criterion": "dietary restriction",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "Kosher"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Dietary restriction of tilapia (due to tilapia fish-based softgel shell)",
            "criterions": [
                {
                    "exact_snippets": "Dietary restriction of tilapia",
                    "criterion": "dietary restriction",
                    "requirements": [
                        {
                            "requirement_type": "food item",
                            "expected_value": "tilapia"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Titanium Dioxide allergy (due to the opaque coloring used in the softgel).",
            "criterions": [
                {
                    "exact_snippets": "Titanium Dioxide allergy",
                    "criterion": "Titanium Dioxide allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}