Medical Cannabis During Chemoradiation for Head and Neck Cancer

Study Overview
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Brief Summary
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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).

Official Title
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A Pilot Study to Assess the Role of Cannabis Added to the Supportive Care Regimen During Chemoradiation for Head and Neck Cancer

Conditions
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Head and Neck Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have histologically confirmed squamous cell carcinoma of the head and neck region planned for definitive or adjuvant treatment with concurrent radiation therapy and systemic therapy Patients may receive platinum-based chemotherapy or cetuximab concurrently with radiation therapy 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 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, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational group<br>Patient dosing options will be stratified into three groups defined as standard, frail/elderly (age > 65 or ECOG 2), and cannabis-experienced (> weekly use of cannabis in the past year outside of NYC Medical Marijuana program). NYC specified cannabis formulation options are defined by THC:CBD ratio as 1:1, low THC:high CBD, high THC:low CBD, and high THC:high CBD. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' adherence to registering for medically certified cannabis | The primary endpoint of aim 1 is a determination of the number of patients registering for medically certified cannabis as assessed as the number (frequency) as well as proportion of patients registering on New York State Medical Marijuana website | Through study completion, an average of 12 months | 
| Patients' adherence to procuring medically certified cannabis | The primary endpoint of aim 2 is a determination of the number of patients procuring medically certified cannabis as assessed as the number (frequency) as well as proportion of patients obtaining marijuana from dispensary. | Through study completion, an average of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time for patients to obtain medically certified cannabis | The primary endpoint of aim 3 is the length of time it takes patients to obtain medically certified cannabis as assessed by the time elapsed in number of days from study enrollment until medically certified cannabis acquisition and use. | Through study completion, an average of 12 months |