{
    "info": {
        "nct_id": "NCT06802172",
        "official_title": "Effect of Meal Timing During Cancer Treatment in Alaska Native Patients: a Randomized Clinical Trial",
        "inclusion_criteria": "* Male or female\n* Self-identify as Alaska Native or American Indian person and eligible for care at the Alaska Native Medical Center\n* Age ≥ 21 years\n* Histologically confirmed rectal cancer stage II or III per AJCC criteria\n* BMI≥18.5 kg/m2\n* Plan to receive either neoadjuvant conventional chemoradiation or total neoadjuvant therapy (TNT) with 5-fluorouracil-based regimens\n* Demonstrate adequate organ and marrow function within two weeks of study treatment initiation\n* Must have capacity to give informed consent\n* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions\nHealthy volunteers allowed\nMust have minimum age of 21 Years",
        "exclusion_criteria": "* Prior neoadjuvant or adjuvant chemotherapy/radiation <12 months prior to rectal cancer occurrence\n* Allergic reaction to any of the treatment agents\n* Any prior pelvic radiotherapy or chemoradiotherapy\n* Major surgery/open biopsy ≤4 weeks prior to enrollment or minor surgery/core biopsy ≤1 week prior to enrollment\n* Currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ\n* History of GI perforation ≤12 months prior to enrollment\n* History of malabsorption, uncontrolled vomiting or diarrhea, or other GI-function affecting disease\n* History of predisposing colonic or small bowel disorders with uncontrolled symptoms\n* Receiving any parenteral nutrition or enteral (tube) feeding or using any other nutritional supplement during the study period\n* History of uncontrolled CHF defined as NYHA Class III or greater\n* Uncontrolled hypertension\n* History of bleeding events, bleeding diathesis, arterial thrombotic events (including TIA, CVA, unstable angina requiring intervention, or MI), or clinically significant PAD and ≤6 months prior to enrollment\n* Pre-existing grade ≥3 neuropathy\n* Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment\n* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)\n* Pregnant or breastfeeding\n* Currently perform overnight shift work more than one day/week on average\n* Regularly eat within an <11-hour period each day\n* Known psychiatric or substance misuse disorders that would interfere with adhering to the requirements of the trial\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation in the trial, or is not in the best interest of the participant to participate, in the opinions of the treating investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male or female",
            "criterions": [
                {
                    "exact_snippets": "Male or female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Self-identify as Alaska Native or American Indian person and eligible for care at the Alaska Native Medical Center",
            "criterions": [
                {
                    "exact_snippets": "Self-identify as Alaska Native or American Indian person",
                    "criterion": "ethnicity",
                    "requirements": [
                        {
                            "requirement_type": "self-identification",
                            "expected_value": [
                                "Alaska Native",
                                "American Indian"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "eligible for care at the Alaska Native Medical Center",
                    "criterion": "eligibility for care",
                    "requirements": [
                        {
                            "requirement_type": "facility",
                            "expected_value": "Alaska Native Medical Center"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 21 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 21 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed rectal cancer stage II or III per AJCC criteria",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed rectal cancer",
                    "criterion": "rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "stage II or III per AJCC criteria",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        },
                        {
                            "requirement_type": "criteria",
                            "expected_value": "AJCC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* BMI≥18.5 kg/m2",
            "criterions": [
                {
                    "exact_snippets": "BMI≥18.5 kg/m2",
                    "criterion": "BMI",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18.5,
                                "unit": "kg/m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Plan to receive either neoadjuvant conventional chemoradiation or total neoadjuvant therapy (TNT) with 5-fluorouracil-based regimens",
            "criterions": [
                {
                    "exact_snippets": "Plan to receive either neoadjuvant conventional chemoradiation",
                    "criterion": "neoadjuvant conventional chemoradiation",
                    "requirements": [
                        {
                            "requirement_type": "plan to receive",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Plan to receive ... total neoadjuvant therapy (TNT) with 5-fluorouracil-based regimens",
                    "criterion": "total neoadjuvant therapy (TNT) with 5-fluorouracil-based regimens",
                    "requirements": [
                        {
                            "requirement_type": "plan to receive",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Demonstrate adequate organ and marrow function within two weeks of study treatment initiation",
            "criterions": [
                {
                    "exact_snippets": "Demonstrate adequate organ and marrow function",
                    "criterion": "organ and marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within two weeks of study treatment initiation",
                    "criterion": "timing of function demonstration",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within two weeks of study treatment initiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have capacity to give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Must have capacity to give informed consent",
                    "criterion": "capacity to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to adhere to the assessments, visit schedules, prohibitions, and restrictions",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to adhere to the assessments",
                    "criterion": "adherence to assessments",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to adhere to the ... visit schedules",
                    "criterion": "adherence to visit schedules",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to adhere to the ... prohibitions",
                    "criterion": "adherence to prohibitions",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing and able to adhere to the ... restrictions",
                    "criterion": "adherence to restrictions",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "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 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": "* Prior neoadjuvant or adjuvant chemotherapy/radiation <12 months prior to rectal cancer occurrence",
            "criterions": [
                {
                    "exact_snippets": "Prior neoadjuvant or adjuvant chemotherapy/radiation <12 months prior to rectal cancer occurrence",
                    "criterion": "prior neoadjuvant or adjuvant chemotherapy/radiation",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Allergic reaction to any of the treatment agents",
            "criterions": [
                {
                    "exact_snippets": "Allergic reaction to any of the treatment agents",
                    "criterion": "allergic reaction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any prior pelvic radiotherapy or chemoradiotherapy",
            "criterions": [
                {
                    "exact_snippets": "prior pelvic radiotherapy",
                    "criterion": "prior pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior pelvic ... chemoradiotherapy",
                    "criterion": "prior pelvic chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery/open biopsy ≤4 weeks prior to enrollment or minor surgery/core biopsy ≤1 week prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "Major surgery/open biopsy ≤4 weeks prior to enrollment",
                    "criterion": "major surgery/open biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "minor surgery/core biopsy ≤1 week prior to enrollment",
                    "criterion": "minor surgery/core biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently active second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ",
            "criterions": [
                {
                    "exact_snippets": "Currently active second malignancy",
                    "criterion": "second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "other than non-melanoma skin cancers",
                    "criterion": "non-melanoma skin cancers",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other than ... cervical carcinoma in situ",
                    "criterion": "cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of GI perforation ≤12 months prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "History of GI perforation ≤12 months prior to enrollment",
                    "criterion": "GI perforation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of malabsorption, uncontrolled vomiting or diarrhea, or other GI-function affecting disease",
            "criterions": [
                {
                    "exact_snippets": "History of malabsorption",
                    "criterion": "malabsorption",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled vomiting",
                    "criterion": "vomiting",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled ... diarrhea",
                    "criterion": "diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other GI-function affecting disease",
                    "criterion": "GI-function affecting disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of predisposing colonic or small bowel disorders with uncontrolled symptoms",
            "criterions": [
                {
                    "exact_snippets": "History of predisposing colonic or small bowel disorders",
                    "criterion": "predisposing colonic or small bowel disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled symptoms",
                    "criterion": "symptoms",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving any parenteral nutrition or enteral (tube) feeding or using any other nutritional supplement during the study period",
            "criterions": [
                {
                    "exact_snippets": "Receiving any parenteral nutrition",
                    "criterion": "parenteral nutrition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "enteral (tube) feeding",
                    "criterion": "enteral feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "using any other nutritional supplement",
                    "criterion": "nutritional supplement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of uncontrolled CHF defined as NYHA Class III or greater",
            "criterions": [
                {
                    "exact_snippets": "History of uncontrolled CHF",
                    "criterion": "congestive heart failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "NYHA Class III or greater",
                    "criterion": "NYHA Class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of bleeding events, bleeding diathesis, arterial thrombotic events (including TIA, CVA, unstable angina requiring intervention, or MI), or clinically significant PAD and ≤6 months prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "History of bleeding events",
                    "criterion": "bleeding events",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "arterial thrombotic events (including TIA, CVA, unstable angina requiring intervention, or MI)",
                    "criterion": "arterial thrombotic events",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant PAD",
                    "criterion": "clinically significant PAD",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "≤6 months prior to enrollment",
                    "criterion": "time since event",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-existing grade ≥3 neuropathy",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing grade ≥3 neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently participating in or has participated in a study of an investigational agent or investigational device ≤4 weeks of the first dose of treatment",
            "criterions": [
                {
                    "exact_snippets": "Currently participating in or has participated in a study of an investigational agent or investigational device",
                    "criterion": "participation in a study of an investigational agent or device",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstable psychiatric, sleep, or circadian conditions (common conditions such as sleep apnea and depression are acceptable as long as they are stabilized and not rapidly worsening)",
            "criterions": [
                {
                    "exact_snippets": "Unstable psychiatric ... conditions",
                    "criterion": "psychiatric conditions",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Unstable ... sleep ... conditions",
                    "criterion": "sleep conditions",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Unstable ... circadian conditions",
                    "criterion": "circadian conditions",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently perform overnight shift work more than one day/week on average",
            "criterions": [
                {
                    "exact_snippets": "Currently perform overnight shift work more than one day/week on average",
                    "criterion": "overnight shift work",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "day/week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Regularly eat within an <11-hour period each day",
            "criterions": [
                {
                    "exact_snippets": "Regularly eat within an <11-hour period each day",
                    "criterion": "eating period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 11,
                                "unit": "hour"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known psychiatric or substance misuse disorders that would interfere with adhering to the requirements of the trial",
            "criterions": [
                {
                    "exact_snippets": "Known psychiatric ... disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "substance misuse disorders",
                    "criterion": "substance misuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation in the trial, or is not in the best interest of the participant to participate, in the opinions of the treating investigator.",
            "criterions": [
                {
                    "exact_snippets": "History or current evidence of any condition",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "therapy",
                    "criterion": "therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}