Medical Cannabis During Chemoradiation for Head and Neck Cancer

Active, not recruiting

• Conditions: Head and Neck Cancer

• Registration Number: NCT03431363
• Lead Sponsor: Albert Einstein College of Medicine

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-03
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-13
• Study Start: 2018-05-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients' adherence to procuring medically certified cannabis	Through study completion, an average of 12 months	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.
Patients' adherence to registering for medically certified cannabis	Through study completion, an average of 12 months	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

Secondary Outcome Measures

Name	Time	Method
Length of time for patients to obtain medically certified cannabis	Through study completion, an average of 12 months	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.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States