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 study about?

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.

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 Treatment assignment

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

Both medications will be taken by mouth

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France

Other Sites

Site Name	City	Country	Status
CHU Gabriel-Montpied	Clermont Ferrand	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.06.2025

Trial locations

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.

Investigated diseases:

Head and neck cancer

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 ID:

2024-519637-32-00

Protocol code:

AOI 2022 SAROUL

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?