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).

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Patients must have histologically confirmed squamous cell carcinoma of the head and neck region planned for definitive or adjuvant radiation therapy and are being certified for medical cannabis
* Patients must receive platinum-based chemotherapy or cetuximab concurrently with radiation therapy
* Patients must be certified to obtain medical marijuana as per New York State Department of Health's Medical Marijuana Program eligibility criteria and guidelines (https://www.health.ny.gov/regulations/medical\_marijuana/faq.htm)
* 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 or prior diagnosis of a psychotic 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

• BACKGROUNDAstrup GL, Rustoen T, Hofso K, Gran JM, Bjordal K. Symptom burden and patient characteristics: Association with quality of life in patients with head and neck cancer undergoing radiotherapy. Head Neck. 2017 Oct;39(10):2114-2126. doi: 10.1002/hed.24875. Epub 2017 Aug 2. PMID 28766791
• BACKGROUNDXiao C, Zhang Q, Nguyen-Tan PF, List M, Weber RS, Ang KK, Rosenthal D, Filion EJ, Kim H, Silverman C, Raben A, Galloway T, Fortin A, Gore E, Winquist E, Jones CU, Robinson W, Raben D, Le QT, Bruner D. Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Standard Radiation Versus Accelerated Radiation Plus Cisplatin for Locally Advanced Head and Neck Carcinoma: NRG Oncology RTOG 0129. Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):667-677. doi: 10.1016/j.ijrobp.2016.07.020. Epub 2016 Jul 25. PMID 27727063
• BACKGROUNDOhri N, Rapkin BD, Guha C, Kalnicki S, Garg M. Radiation Therapy Noncompliance and Clinical Outcomes in an Urban Academic Cancer Center. Int J Radiat Oncol Biol Phys. 2016 Jun 1;95(2):563-70. doi: 10.1016/j.ijrobp.2016.01.043. Epub 2016 Jan 30. PMID 27020104
• BACKGROUNDBanta-Green CJ, Von Korff M, Sullivan MD, Merrill JO, Doyle SR, Saunders K. The prescribed opioids difficulties scale: a patient-centered assessment of problems and concerns. Clin J Pain. 2010 Jul-Aug;26(6):489-97. doi: 10.1097/AJP.0b013e3181e103d9. PMID 20551723
• BACKGROUNDBrowman GP, Levine MN, Hodson DI, Sathya J, Russell R, Skingley P, Cripps C, Eapen L, Girard A. The Head and Neck Radiotherapy Questionnaire: a morbidity/quality-of-life instrument for clinical trials of radiation therapy in locally advanced head and neck cancer. J Clin Oncol. 1993 May;11(5):863-72. doi: 10.1200/JCO.1993.11.5.863. PMID 8487051
• BACKGROUNDPiomelli D. The molecular logic of endocannabinoid signalling. Nat Rev Neurosci. 2003 Nov;4(11):873-84. doi: 10.1038/nrn1247. No abstract available.