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 supportive care regimen undergoing treatment with definitive or adjuvant concurrent chemoradiation (CRT).
Brief Title
Medical Cannabis During Chemoradiation for Head and Neck Cancer
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Head and Neck Cancer
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03431363
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2017-8493
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Pilot Study to Assess the Role of Cannabis Added to the Supportive Care Regimen During Chemoradiation for Head and Neck Cancer
Primary Outcomes
Outcome Description
The primary endpoint of aim 1 is a determination of the number of patients registering for medically certified cannabis as assessed as the number (frequency) as well as proportion of patients registering on New York State Medical Marijuana website
Outcome Measure
Patients' adherence to registering for medically certified cannabis
Outcome Time Frame
Through study completion, an average of 12 months
Outcome Description
The primary endpoint of aim 2 is a determination of the number of patients procuring medically certified cannabis as assessed as the number (frequency) as well as proportion of patients obtaining marijuana from dispensary.
Outcome Measure
Patients' adherence to procuring medically certified cannabis
Outcome Time Frame
Through study completion, an average of 12 months
Secondary Outcomes
Outcome Description
The primary endpoint of aim 3 is the length of time it takes patients to obtain medically certified cannabis as assessed by the time elapsed in number of days from study enrollment until medically certified cannabis acquisition and use.
Outcome Time Frame
Through study completion, an average of 12 months
Outcome Measure
Length of time for patients to obtain medically certified cannabis
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients with head and neck cancer that meet the eligibility criteria as described above
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rafi Kabarriti
Investigator Email
RKABARRI@MONTEFIORE.ORG