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 range
18 Years
Sex
ALL
See this in plain English?
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, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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