Medical Cannabis During Chemoradiation for Head and Neck Cancer

NCT03431363 | Completed DMC

• 1 other identifier: 2017-8493
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (3)

• Patients' adherence to registering for medically certified cannabis - Aim 1

  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. Patients' adherence percentage will be presented along with Clopper-Pearson exact 95% confidence interval.

  Through study completion, up to 6 months

• Patients' adherence to procuring medically certified cannabis - Aim 2

  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 procuring marijuana from dispensary. Patients' adherence percentage will be presented along with Clopper-Pearson exact 95% confidence interval.

  Through study completion, up to 6 months

• Duration 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. Time to cannabis acquisition will be summarized using Kaplan-Meier product limit estimator.

  Through study completion, up to 6 months

Secondary Outcomes (3)

• Recovery based on Head and Neck Radiotherapy Questionnaire (HNRQ)

  1-2 weeks, 4-6 weeks, 3 months, 6 months, and 12 months post-treatment

• Recovery based on Performance Status Scale for Head and Neck Cancer (PSS-HN)

  1-2 weeks, 4-6 weeks, 3 months, 6 months, and 12 months post-treatment

• Recovery of Spitzer Quality of Life Index (SQLI)

  1-2 weeks, 4-6 weeks, 3 months, 6 months, and 12 months post-treatment

Study Arms (1)

Observational group

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with head and neck cancer that meet the eligibility criteria as described.

You may qualify if:

• 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.

You may not qualify if:

• 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, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Sponsors & Collaborators

• Cosmos Technical Center: collaborator
• Albert Einstein College of Medicine: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (20)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (less than 10 mL in an EDTA tube), urine (less than 15 mL), and oral swab samples will be collected from patients at baseline, once during weeks 1-2, once during week 5-6, and at the time of post-treatment follow-up appointments. Blood tests are routinely performed on a weekly basis for patients receiving systemic therapy and all attempts will be made to coordinate biospecimen collection for study purposes with biospecimen collection for standard clinical care in order to minimize patient inconvenience. Each specimen will be analyzed in the Stable Isotope \& Metabolomics Core Facility of the Diabetes Research Center under the direction of Dr. Irwin Kurland.

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Rafi Kabarriti, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2017
• First Posted: February 13, 2018
• Study Start: May 18, 2018
• Primary Completion: July 21, 2025
• Study Completion: January 14, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)