Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Alyssa Asaro, BA
718-920-5636
aasaro@montefiore.org

More Details

NCT ID
NCT03431363
Status
Recruiting
Sponsor
Albert Einstein College of Medicine

Study Contact

Alyssa Asaro
718-920-5636
aasaro@montefiore.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.