{
    "info": {
        "nct_id": "NCT05935891",
        "official_title": "A Feasibility Study of Topical Cannabinoids for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in Adults With Hormone Receptor-Positive Breast Cancer (CanAroma)",
        "inclusion_criteria": "* Age 18 years or above at the time of signing the informed consent form.\n* Histologically proven diagnosis of stage I-III invasive breast cancer.\n* Currently taking prescribed dose of an aromatase inhibitor (e.g., anastrazole, letrozole, exemestane) for at least 60 days with a plan to continue for at least 4 weeks after time of consent.\n* Initiated AI therapy must have been within 48 months at time of consent.\n* Experiencing AIMSS in hands and/or wrists for at least 4 weeks prior to time of consent.\n* Patients must have reported a score of 4 or higher on at least one of the four M-SACRAH questions regarding pain and stiffness in hands and/or wrists over the past 7 days. Patients experiencing AIMSS symptoms in other joints are eligible, but must have pain in hands and/or wrists.\n* Must be willing and able to comply with study visits and procedures.\n* Must be willing to be registered in the Minnesota Medical Cannabis Program (MMCP).\n* Must meet qualifications for the Minnesota Medical Cannabis\n\nProgram (MMCP). This includes:\n\n1. Must have a qualifying condition, as per MMCP requirements, that is certified by a Health Care Practitioner.\n2. Must be a Minnesota resident.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* The patient is currently using or has used cannabinoids within 4 weeks of time of consent.\n* Active skin lesions on hands/wrists that the investigator feels could impair absorption of cannabinoid cream or lead to increased toxicity (e.g., psoriasis, cellulitis, cutaneous lupus erythematosus, hand-foot syndrome).\n* Plan to start or increase doses of other analgesics aimed at improving AIMSS symptoms (e.g., duloxetine, non-steroidal anti- inflammatories, acetaminophen, opioids). Of note, patients are eligible if they have remained on stable doses of AIMSS related medications for 4 weeks prior to time of consent and do not plan to escalate the dose.\n* Current or planned initiation of acupuncture to arms, wrists or hands within study period.\n* Any known or suspected hypersensitivity to topical cannabinoids.\n* Any condition that the investigator believes would interfere with the ability to provide informed consent, comply with the study protocol, or would put the subject at undue risk.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age 18 years or above at the time of signing the informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or above",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically proven diagnosis of stage I-III invasive breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven diagnosis",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "stage I-III invasive breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "stage"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "stage"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently taking prescribed dose of an aromatase inhibitor (e.g., anastrazole, letrozole, exemestane) for at least 60 days with a plan to continue for at least 4 weeks after time of consent.",
            "criterions": [
                {
                    "exact_snippets": "Currently taking prescribed dose of an aromatase inhibitor (e.g., anastrazole, letrozole, exemestane)",
                    "criterion": "aromatase inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 60 days",
                    "criterion": "duration of aromatase inhibitor use",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with a plan to continue for at least 4 weeks after time of consent",
                    "criterion": "planned continuation of aromatase inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "planned duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Initiated AI therapy must have been within 48 months at time of consent.",
            "criterions": [
                {
                    "exact_snippets": "Initiated AI therapy must have been within 48 months",
                    "criterion": "AI therapy initiation",
                    "requirements": [
                        {
                            "requirement_type": "time since initiation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 48,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Experiencing AIMSS in hands and/or wrists for at least 4 weeks prior to time of consent.",
            "criterions": [
                {
                    "exact_snippets": "Experiencing AIMSS in hands and/or wrists",
                    "criterion": "AIMSS",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "hands",
                                "wrists"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 4 weeks prior to time of consent",
                    "criterion": "duration of AIMSS",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have reported a score of 4 or higher on at least one of the four M-SACRAH questions regarding pain and stiffness in hands and/or wrists over the past 7 days. Patients experiencing AIMSS symptoms in other joints are eligible, but must have pain in hands and/or wrists.",
            "criterions": [
                {
                    "exact_snippets": "reported a score of 4 or higher on at least one of the four M-SACRAH questions regarding pain and stiffness in hands and/or wrists over the past 7 days",
                    "criterion": "M-SACRAH score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "hands",
                                "wrists"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 7 days"
                        }
                    ]
                },
                {
                    "exact_snippets": "experiencing AIMSS symptoms in other joints are eligible, but must have pain in hands and/or wrists",
                    "criterion": "AIMSS symptoms",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "hands",
                                "wrists"
                            ]
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be willing and able to comply with study visits and procedures.",
            "criterions": [
                {
                    "exact_snippets": "Must be willing and able to comply with study visits and procedures.",
                    "criterion": "compliance with study visits and procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must be willing to be registered in the Minnesota Medical Cannabis Program (MMCP).",
            "criterions": [
                {
                    "exact_snippets": "Must be willing to be registered in the Minnesota Medical Cannabis Program (MMCP).",
                    "criterion": "willingness to register in MMCP",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must meet qualifications for the Minnesota Medical Cannabis",
            "criterions": [
                {
                    "exact_snippets": "Must meet qualifications for the Minnesota Medical Cannabis",
                    "criterion": "qualifications for the Minnesota Medical Cannabis",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Must have a qualifying condition, as per MMCP requirements, that is certified by a Health Care Practitioner.",
            "criterions": [
                {
                    "exact_snippets": "Must have a qualifying condition, as per MMCP requirements",
                    "criterion": "qualifying condition",
                    "requirements": [
                        {
                            "requirement_type": "certification",
                            "expected_value": "certified by a Health Care Practitioner"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Must be a Minnesota resident.",
            "criterions": [
                {
                    "exact_snippets": "Must be a Minnesota resident",
                    "criterion": "residency",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "Minnesota"
                        }
                    ]
                }
            ]
        },
        {
            "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 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* The patient is currently using or has used cannabinoids within 4 weeks of time of consent.",
            "criterions": [
                {
                    "exact_snippets": "currently using or has used cannabinoids within 4 weeks of time of consent",
                    "criterion": "cannabinoid use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active skin lesions on hands/wrists that the investigator feels could impair absorption of cannabinoid cream or lead to increased toxicity (e.g., psoriasis, cellulitis, cutaneous lupus erythematosus, hand-foot syndrome).",
            "criterions": [
                {
                    "exact_snippets": "Active skin lesions on hands/wrists",
                    "criterion": "active skin lesions",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "hands",
                                "wrists"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "the investigator feels could impair absorption of cannabinoid cream",
                    "criterion": "impair absorption of cannabinoid cream",
                    "requirements": [
                        {
                            "requirement_type": "investigator assessment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the investigator feels could ... lead to increased toxicity",
                    "criterion": "increased toxicity",
                    "requirements": [
                        {
                            "requirement_type": "investigator assessment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "e.g., psoriasis, cellulitis, cutaneous lupus erythematosus, hand-foot syndrome",
                    "criterion": "specific skin conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "psoriasis",
                                "cellulitis",
                                "cutaneous lupus erythematosus",
                                "hand-foot syndrome"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Plan to start or increase doses of other analgesics aimed at improving AIMSS symptoms (e.g., duloxetine, non-steroidal anti- inflammatories, acetaminophen, opioids). Of note, patients are eligible if they have remained on stable doses of AIMSS related medications for 4 weeks prior to time of consent and do not plan to escalate the dose.",
            "criterions": [
                {
                    "exact_snippets": "Plan to start or increase doses of other analgesics aimed at improving AIMSS symptoms",
                    "criterion": "analgesic dose change",
                    "requirements": [
                        {
                            "requirement_type": "plan",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients are eligible if they have remained on stable doses of AIMSS related medications for 4 weeks prior to time of consent",
                    "criterion": "stable dose of AIMSS related medications",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "do not plan to escalate the dose",
                    "criterion": "dose escalation plan",
                    "requirements": [
                        {
                            "requirement_type": "plan",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or planned initiation of acupuncture to arms, wrists or hands within study period.",
            "criterions": [
                {
                    "exact_snippets": "Current or planned initiation of acupuncture to arms, wrists or hands",
                    "criterion": "acupuncture",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "arms",
                                "wrists",
                                "hands"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "current or planned within study period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any known or suspected hypersensitivity to topical cannabinoids.",
            "criterions": [
                {
                    "exact_snippets": "Any known or suspected hypersensitivity to topical cannabinoids.",
                    "criterion": "hypersensitivity to topical cannabinoids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition that the investigator believes would interfere with the ability to provide informed consent, comply with the study protocol, or would put the subject at undue risk.",
            "criterions": [
                {
                    "exact_snippets": "Any condition that the investigator believes would interfere with the ability to provide informed consent",
                    "criterion": "condition affecting informed consent",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any condition that the investigator believes would ... comply with the study protocol",
                    "criterion": "condition affecting protocol compliance",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Any condition that the investigator believes would ... put the subject at undue risk",
                    "criterion": "condition putting subject at undue risk",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "undue"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Program (MMCP). This includes:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}