Status:
ACTIVE_NOT_RECRUITING
Medical Cannabis During Chemoradiation for Head and Neck Cancer
Lead Sponsor:
Albert Einstein College of Medicine
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03431363
Start Date
May 18 2018
End Date
January 1 2026
Last Update
January 7 2025
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467