OBSERVATIONALCOMPLETEDNCT03431363

A Pilot Study to Assess the Role of Cannabis Added to the Supportive Care Regimen 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).

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-03-05

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: Not reported
Enrollment: 30 (ACTUAL)
Start date: 2018-05-18
Sponsor: Albert Einstein College of Medicine
Design: Not reported
Locations: 1
Results record: Not present in registry snapshot

Patients undergoing intensive treatment for locally advanced Head and Neck Cancer (HNC) with definitive or adjuvant concurrent chemoradiation (CRT) typically experience high levels of acute treatment toxicity due to the unavoidable irradiation of normal tissues in the upper aerodigestive tract adjacent to tumor and nodal target structures such as pharyngeal constrictors, salivary glands, oral cavity, and the upper esophagus. Radiation dose to these structures has been substantially reduced with the widespread adoption of advanced treatment planning and delivery techniques such as intensity-modulated radiation therapy (IMRT) and image-guided radiation therapy (IGRT), however patients continue to experience significant toxicity due to local effects of radiotherapy. Treatment toxicity due to local effects increases synergistically with the addition of concurrent chemotherapy, and additional toxicities such as myelosuppression and chemotherapy induced nausea/vomiting can be introduced with the addition of concurrent chemotherapy. Acute treatment toxicities include significant mucositis, odynophagia, nausea, anorexia, weight loss leading to severe reductions in health-related quality of life (HRQoL) domains related to eating, tasting, and overall sense of wellbeing. These effects generally build up over the course of a typical radiotherapy schedule (six to eight weeks), continue to persist after treatment, and demonstrate a gradual improvement over a typical course of three to six months post-treatment. Treatment toxicity and their resultant treatment burden are typically managed with a regimen of medications directed at specific cell receptor targets involved in pain signaling, inflammation, nausea/vomiting and occasionally supplemented by topical agents intended to protect mucosal surfaces and provide local pain relief. Notably, patients often require high dose opiate analgesics to achieve adequate pain relief, exposing patients to risks of opiate dependence and the constellation of adverse effects associated with chronic opiate use. Overall, in spite of maximal treatment with currently available agents, patients continue to experience significant reduction in QoL during and after CRT attributable to both treatment-related toxicity and adverse effects of opiate analgesics utilized to alleviate treatment-related pain. Cannabis is defined as products derived from the Cannabis sativa plant leaf. Cannabis consists of numerous bioactive compounds collectively referred to as cannabinoids. The most studied and best characterized cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD). Cannabinoids interact with endogenous cannabinoid receptors to produce biologic effects. Two types of cannabinoid receptors, CB1 and CB2, have been identified and characterized to date. CB1 receptors are primarily expressed in the CNS and GI tract whereas CB2 receptors are primarily expressed in immune cells, particularly circulating B-lymphocytes. Collectively, CB receptors are involved in cellular pathways regulating pain, nausea, appetite, and mood Cannabis derivatives such as tetrahydrocannabinol (THC) and cannabidiol (CBD) have demonstrated anti-inflammatory, anti-emetic, analgesic, and appetite stimulatory activity in clinical use in humans. Pre-clinical studies with tumor cell lines have also demonstrated anti-neoplastic activity. Trials evaluating cannabis have shown synergistic anti-emetic effects with commonly used agents such as prochloperazine and ondansetron and synergistic analgesic effects with opiates. Cannabis was also shown to reduce opiate requirements and consequent opiate related toxicity for acute and chronic cancer-related pain. Of note, cannabis and cannabinoids have a favorable safety profile compared to opioid analgesics with significantly lower addictive potential and carry a lower risk of potentially serious cardiovascular toxicity (QTc prolongation) or systemic toxicity (serotonin syndrome) compared to commonly utilized anti-emetic agents. In fact, the potential lethal dose in humans has been estimated in the range of 650-700 kg inhaled in 15 minutes, making overdose highly unlikely. As a result, cannabis has recently been approved in many states within the USA for medical use, including New York state. Physician and patient enthusiasm for medical use of cannabis is high, however clinical data clarifying the role of cannabis in the treatment armamentarium for a variety of disease conditions including cancer is currently limited. Many of the common acute symptoms experienced by HNC patients during CRT involve physiologic pathways in which cannabinoid receptors have been implicated. Therefore, given the favorable safety profile of cannabis derivatives and potential synergistic effects with commonly used medications for relief of these treatment toxicities, we hypothesize that the addition of cannabis to the supportive care regimen will improve symptom burden during and immediately post-treatment resulting in improved HRQoL and may also decrease weight loss and opiate analgesic requirement.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

No structured intervention was reported.

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

Study population

Patients with head and neck cancer that meet the eligibility criteria as described.

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

primary outcomes

primary measures

Patients' adherence to registering for medically certified cannabis - Aim 1

Time frame: Through study completion, up to 6 months

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. Patients' adherence percentage will be presented along with Clopper-Pearson exact 95% confidence interval.

Patients' adherence to procuring medically certified cannabis - Aim 2

Time frame: Through study completion, up to 6 months

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 procuring marijuana from dispensary. Patients' adherence percentage will be presented along with Clopper-Pearson exact 95% confidence interval.

Duration of time for patients to obtain medically certified cannabis

Time frame: Through study completion, up to 6 months

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. Time to cannabis acquisition will be summarized using Kaplan-Meier product limit estimator.

secondary outcomes

secondary measures

Recovery based on Head and Neck Radiotherapy Questionnaire (HNRQ)

Time frame: 1-2 weeks, 4-6 weeks, 3 months, 6 months, and 12 months post-treatment

Recovery based on HNRQ will be assessed by the difference in HNRQ between time points. HNRQ is a validated, 22-item, disease-specific, multidimensional tool designed to measure acute morbidity and health-related quality of life (QOL) in head and neck cancer (HNC) patients undergoing radiation therapy (RT). It assesses symptoms like mucositis, dysphagia, and xerostomia, providing crucial data for clinical trials and treatment monitoring. The HNRQ focuses on the patient's experience during the preceding 7 days, with 22 items usually scored on a 1-7 Likert-type scale, where lower scores indicate poorer QOL. Results will be summarized using descriptive statistics and changes will be examined using Wilcoxon sign test.

Recovery based on Performance Status Scale for Head and Neck Cancer (PSS-HN)

Time frame: 1-2 weeks, 4-6 weeks, 3 months, 6 months, and 12 months post-treatment

Recovery based PSS-HN will be assessed by the difference in PSS-HN between time points. PSS-HN is a clinician-rated, 3-item tool assessing functional, disease-specific outcomes (diet, public eating, speech) on a 0-100 scale, where higher scores indicate better function. Results will be summarized using descriptive statistics and changes will be examined using Wilcoxon sign test.

Recovery of Spitzer Quality of Life Index (SQLI)

Time frame: 1-2 weeks, 4-6 weeks, 3 months, 6 months, and 12 months post-treatment

Recovery based on SQLI will be assessed by the difference in SQLI between time points. Results will be summarized using descriptive statistics and changes will be examined using Wilcoxon sign test.

Publications

Locally readable linked articles

background reference

A review of oral cannabinoids and medical marijuana for the treatment of chemotherapy-induced nausea and vomiting: a focus on pharmacokinetic variability and pharmacodynamics.

Cancer Chemotherapy and Pharmacology · Free full text

Snapshot provenance

Snapshot: 051ad494-20f1-4765-a0ad-d5de9c7210d0
Retrieved: 11/09/2026, 14:54:54
SHA-256: 7eea8c529cfbb0c81793748b34cae7cfb91fda48726cfdab597113845a7f5ded