Medical Cannabis During Chemoradiation for Head and Neck Cancer
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
🗓️ Study Start (Actual) 18 May 2018
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 30
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Bronx, New York, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 December 2017
  • First Submitted that Met QC Criteria 6 February 2018
  • First Posted 13 February 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 January 2024
  • Last Update Posted 5 January 2024
  • Last Verified January 2024