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Head and Neck CancerNCT03431363

Medical Cannabis During Chemoradiation for Head and Neck Cancer

An observational study of Head and Neck Cancer, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
How many people
30 participants
Where
1 siteUnited States
Study dates
18 May 2018to 14 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: 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).

Read the detailed description

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.

Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03431363
Study groupRoleWhat they receive
Observational groupPatient dosing options will be stratified into three groups defined as standard, frail/elderly (age > 65 or ECOG 2), and cannabis-experienced (> weekly use of cannabis in the past year outside of NYC Medical Marijuana program). NYC specified cannabis formulation options are defined by THC:CBD ratio as 1:1, low THC:high CBD, high THC:low CBD, and high THC:high CBD.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Through study completion, up to 6 months

  2. Patients' adherence to procuring medically certified cannabis - Aim 2

    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.

    Measured: Through study completion, up to 6 months

  3. Duration of time for patients to obtain medically certified cannabis

    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.

    Measured: Through study completion, up to 6 months

Secondary outcomes (3)

  1. Recovery based on Head and Neck Radiotherapy Questionnaire (HNRQ)

    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.

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

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

    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.

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

  3. Recovery of Spitzer Quality of Life Index (SQLI)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2018
  2. Study start18 May 2018
  3. Primary completion21 Jul 2025
  4. Study completion14 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03431363
Sponsor's protocol ID
2017-8493
Status last verified
Mar 2026
First submitted
3 Dec 2017
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Astrup 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.

    PubMed 28766791

  • Xiao 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.

    PubMed 27727063

  • Ohri 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.

    PubMed 27020104

  • Banta-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.

    PubMed 20551723

  • Browman 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.

    PubMed 8487051

  • Piomelli D. The molecular logic of endocannabinoid signalling. Nat Rev Neurosci. 2003 Nov;4(11):873-84. doi: 10.1038/nrn1247. No abstract available.

    PubMed 14595399

  • Martin BR, Wiley JL. Mechanism of action of cannabinoids: how it may lead to treatment of cachexia, emesis, and pain. J Support Oncol. 2004 Jul-Aug;2(4):305-14; discussion 314-6.

    PubMed 15357514

  • Wilkie G, Sakr B, Rizack T. Medical Marijuana Use in Oncology: A Review. JAMA Oncol. 2016 May 1;2(5):670-675. doi: 10.1001/jamaoncol.2016.0155.

    PubMed 26986677

  • Degenhardt L, Lintzeris N, Campbell G, Bruno R, Cohen M, Farrell M, Hall WD. Experience of adjunctive cannabis use for chronic non-cancer pain: findings from the Pain and Opioids IN Treatment (POINT) study. Drug Alcohol Depend. 2015 Feb 1;147:144-50. doi: 10.1016/j.drugalcdep.2014.11.031. Epub 2014 Dec 10.

    PubMed 25533893

  • Hall W, Christie M, Currow D. Cannabinoids and cancer: causation, remediation, and palliation. Lancet Oncol. 2005 Jan;6(1):35-42. doi: 10.1016/S1470-2045(04)01711-5.

    PubMed 15629274

  • Badowski ME. 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 Chemother Pharmacol. 2017 Sep;80(3):441-449. doi: 10.1007/s00280-017-3387-5. Epub 2017 Aug 5.

    PubMed 28780725

  • Engels FK, de Jong FA, Mathijssen RH, Erkens JA, Herings RM, Verweij J. Medicinal cannabis in oncology. Eur J Cancer. 2007 Dec;43(18):2638-44. doi: 10.1016/j.ejca.2007.09.010. Epub 2007 Oct 31.

    PubMed 17976975

  • Adler JN, Colbert JA. Clinical decisions. Medicinal use of marijuana--polling results. N Engl J Med. 2013 May 30;368(22):e30. doi: 10.1056/NEJMclde1305159. No abstract available.

    PubMed 23718175

  • Bowles DW, O'Bryant CL, Camidge DR, Jimeno A. The intersection between cannabis and cancer in the United States. Crit Rev Oncol Hematol. 2012 Jul;83(1):1-10. doi: 10.1016/j.critrevonc.2011.09.008. Epub 2011 Oct 21.

    PubMed 22019199

  • Spitzer WO, Dobson AJ, Hall J, Chesterman E, Levi J, Shepherd R, Battista RN, Catchlove BR. Measuring the quality of life of cancer patients: a concise QL-index for use by physicians. J Chronic Dis. 1981;34(12):585-97. doi: 10.1016/0021-9681(81)90058-8. No abstract available.

    PubMed 7309824

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Cancer, run by Albert Einstein College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients' adherence to registering for medically certified cannabis - Aim 1 (time frame: Through study completion, up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03431363, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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