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Study of Cannabidiol and Nutritional Supplements to Improve Muscle Health in Adults with Head and Neck Cancer Before Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Head and Neck Cancer, specifically studying how cannabidiol (CBD) combined with nutritional supplements might help improve muscle health. The study will use Arvisol, a tablet form of CBD, or a placebo tablet. The treatment aims to enhance muscle function and strength before and after cancer treatment.

The main purpose of this research is to examine how CBD affects muscle health and energy production in muscle cells (mitochondrial activity) in people with head and neck cancer. Participants will take either Arvisol tablets or placebo tablets along with nutritional supplements for up to 21 days. The maximum daily dose of the medication will be 450 mg.

During the study, researchers will monitor various aspects of muscle health using different measurement techniques. They will assess muscle strength, muscle mass, and overall physical performance. The study will also track how well participants tolerate the treatment by monitoring their appetite and any digestive issues they may experience. Additionally, the research team will evaluate how the cancer responds to treatment using medical imaging.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo initial tests including CT scan to assess muscle mass at the third lumbar vertebra level

    Medical staff will measure your muscle strength through forearm grip tests and physical performance battery test

    Your body composition will be evaluated using an impedance measurement technique

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either Arvisol 150mg tablets or placebo tablets

    Both medications will be taken by mouth

  3. Step 3

    Daily monitoring

    During the first 3 days of taking the medication, your response will be closely monitored

    You will need to report any changes in appetite and digestive issues, particularly nausea and vomiting

    Your tobacco and alcohol consumption will be recorded daily

  4. Step 4

    Weekly assessments

    Throughout the treatment period, you will have weekly check-ups

    Your overall health status will be monitored

    Changes in appetite and digestive system function will be recorded

  5. Step 5

    Final evaluation

    A second CT scan will be performed to measure changes in muscle mass

    Repeat muscle strength and physical performance tests will be conducted

    Body composition will be measured again using impedance technique

    Tumor size will be evaluated using CT scan

  6. Step 6

    Post-treatment monitoring

    For 7 days after stopping the medication, you will be monitored daily

    Any withdrawal symptoms will be recorded

    Your tobacco and alcohol consumption will continue to be monitored daily during this period

Who can join the trial?

8 criteria

  • Diagnosis of squamous cell carcinoma (a type of skin cancer) in the head and neck area (including mouth, throat, voice box) or high likelihood of having this type of cancer based on doctor's assessment
  • Having a mild to moderate nutritional risk (stage 2 or 3 according to study classification)
  • Must provide informed consent to participate in the study
  • For women who can become pregnant:
    • Must not be currently pregnant
    • Must use effective birth control during treatment with CBD (cannabidiol) and for 7 days after treatment ends
    • Must have a mobile phone to allow monitoring of treatment tolerance and appetite while taking CBD
    • Must be an adult (18 years or older)
    • Can be either male or female

Who cannot join the trial?

15 criteria

  • Age below 18 or above 65 years old
  • Previous allergic reactions to cannabidiol (CBD) or hemp-derived products
  • Current pregnancy or breastfeeding
  • Active substance abuse or addiction
  • Severe liver problems (as CBD is processed by the liver)
  • Taking medications that interact with CBD, such as blood thinners
  • Uncontrolled psychiatric conditions
  • History of adverse reactions to nutritional supplements
  • Inability to follow study procedures or provide informed consent
  • Participation in another clinical trial within the past 30 days
  • Unstable medical conditions that could interfere with the study
  • History of severe cardiovascular disease
  • Current use of medical marijuana or CBD products
  • Impaired kidney function (problems with kidney working properly)
  • Inability to swallow supplements or medications
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Investigated drugs

  • Cannabidiol (CBD)

    is a natural compound derived from the cannabis plant. It does not cause a "high" feeling and is being studied for its potential therapeutic benefits. In this trial, it is used alongside nutritional supplements to potentially help improve muscle health in head and neck cancer patients before and after surgery. CBD may help protect muscle tissue and support mitochondrial function, which is important for muscle energy and strength.

  • Nutritional supplementation

    refers to additional nutrients provided to patients to support their overall health and muscle function. These supplements are designed to provide extra nutrition beyond what patients get from their regular diet, which can be especially important for cancer patients preparing for surgery.

What is already known about the treatment

Cannabidiol (CBD) - A naturally occurring compound administered orally in the form of nutritional supplements, which is being studied for its potential benefits in head and neck cancer patients undergoing surgery. This non-psychoactive substance derived from cannabis plants works by interacting with the endocannabinoid system and has shown promising effects on muscle health and mitochondrial function. CBD is classified as a cannabinoid that has been gaining significant attention in medical research for its therapeutic properties, including anti-inflammatory effects and potential muscle preservation capabilities. The medication is currently being investigated in clinical trials as a prehabilitation supplement to improve muscle health and mitochondrial activity in cancer patients before and after surgery.

Investigated diseases

Head and Neck Cancer - A group of cancers that begins in the cells that make up the head and neck regions, including the mouth, throat, voice box, and sinuses. The disease typically starts in the squamous cells that line the moist surfaces inside these areas. As the cancer develops, it can cause swelling, pain, difficulty swallowing, voice changes, and lumps in the neck area. The condition may affect speech, eating, and breathing as it progresses. The disease can spread to nearby tissues and lymph nodes in the neck.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519637-32-00Protocol codeAOI 2022 SAROULEstimated enrolment30 patientsSponsorUniversity Hospital Of Clermont-Ferrand

sourced from the EU Clinical Trials Register and site verification

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