Medical Cannabis During Chemoradiation for Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03431363
• Other study ID #: 2017-8493
• Status: Recruiting
• Start date: May 18, 2018
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Albert Einstein College of Medicine
• Contact: Rachel Kaufman
• Phone: 718-920-5636
• Email: rkaufman[@]montefiore.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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