Medical Cannabis During Chemoradiation for Head and Neck Cancer (NCT03431363) | Clinical Trial Compass
CompletedNot Applicable
Medical Cannabis During Chemoradiation for Head and Neck Cancer
United States30 participantsStarted 2018-05-18
Plain-language summary
The primary purpose of the study is to observe the adherence and health seeking behavior of patients with Head and Neck cancer (HNC) certified to obtain medically certified cannabis as part of their supportive care regimen undergoing treatment with definitive or adjuvant concurrent chemoradiation (CRT).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically confirmed squamous cell carcinoma of the head and neck region planned for definitive or adjuvant radiation therapy and are being certified for medical cannabis
* Patients must receive platinum-based chemotherapy or cetuximab concurrently with radiation therapy
* Patients must be certified to obtain medical marijuana as per New York State Department of Health's Medical Marijuana Program eligibility criteria and guidelines (https://www.health.ny.gov/regulations/medical\_marijuana/faq.htm)
* Age \>=18 years and ECOG performance status \<=2 (Karnofsky \>=60)
* Patients must be willing to use medically certified cannabis as directed after study enrollment
* Patients must be able to read English, Spanish, or French fluently
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Prior diagnosis of cannabis use disorder as defined in the DSM-V
* Current or prior diagnosis of a psychotic disorder as defined in the DSM-V
* Current opioid use disorder on maintenance opioid therapy
* Current active use of smoked cannabis or cannabis derivatives AND unwillingness to cease use of non-medically certified cannabis for the duration of study participation
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cannabis derivatives
* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, …
What they're measuring
1
Patients' adherence to registering for medically certified cannabis - Aim 1
Timeframe: Through study completion, up to 6 months
2
Patients' adherence to procuring medically certified cannabis - Aim 2
Timeframe: Through study completion, up to 6 months
3
Duration of time for patients to obtain medically certified cannabis
Timeframe: Through study completion, up to 6 months