Medical Cannabis During Chemoradiation for Head and Neck Cancer

Albert Einstein College of Medicine

Status: Active, not recruiting

Conditions: Head and Neck Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03431363

2017-8493

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Observational group

Description:

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.