Effect of Cannabidiol on Muscle Mass and Mitochondrial Function in Head and Neck Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Hospital Of Clermont-Ferrand

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Decision date (initial)

2025-09-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU de Clermont-Ferrand

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Improvement of muscle health assessed by muscle mitochondrial activity perioperatively by adding cannabidiol (CBD) to nutritional supplementation in head and neck cancer

Secondary objectives 6

1. Ensure the absence of pro-neoplastic effect of the addition of CBD by CT method
2. Ensure the absence of anorectic effect of CBD over a short period of addition to nutritional supplementation
3. Ensure the absence of withdrawal syndrome or addictive behavior to CBD following this addition to nutrition over a short period
4. Evaluate the tolerance to CBD as part of this preoperative supplementation
5. Compare between randomization groups the improvement in muscle health in terms of function and muscle mass
6. Compare between randomization groups the reduction in serum systemic inflammation in the preoperative period

Conditions and MedDRA coding

Head and Neck Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, larynx or prevalent lymphadenopathy) or high probability of squamous cell carcinoma of the head and neck according to the judgment of the investigator (without histological confirmation)
2. Stage 2 or 3 nutritional risk according to the classification specific to this study (light to moderate nutritional risk)
3. Consent to participate in the study
4. For women of childbearing age: absence of current pregnancy and effective contraceptive method for the duration of treatment with CBD and up to 7 days after the end of treatment
5. To have of a means of communication (mobile phone) to monitor tolerance and appetite while taking CBD

Exclusion criteria 10

1. History of severe heart failure, severe respiratory failure, severe renal failure, severe chronic obstructive pulmonary disease, uncontrolled insulin-dependent diabetes or uncontrolled coronary artery disease
2. Pregnant and breastfeeding women
3. Persons under curatorship, guardianship, protection of justice or deprived of liberty
4. Age <18 years
5. History of chemotherapy or radiotherapy for head and neck cancer
6. Malnutrition prior to the onset of head and neck cancer
7. Morbid obesity
8. Absence of nutritional risk (grade 1) or severe nutritional risk requiring urgent renutrition (grade 4) during the nutritional assessment
9. History of epilepsy
10. Addiction to other drugs or cannabis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change of at least 50% in muscle mitochondrial activity between the time of the panendoscopy and the time of surgery (or of the consultation, if no surgery is planned for the therapeutic management of the patient)

Secondary endpoints 7

1. Evaluation of tolerance to CBD by measuring appetite and the presence of digestive disorders (particularly in terms of nausea and vomiting) on ​​a daily basis during the period of addition of CBD to the nutritional supplementation.
2. Présence de signes de sevrage et ou de manques au CBD dans les 7 jours suivant l’arrêt de la consommation de CBD
3. Measures the first 3 days of taking CBD then weekly during the period of CBD consumption and daily for 7 days after stopping CBD consumption and daily consumption of tobacco and alcohol
4. Muscular functional capacity assessed before panendoscopy and after the addition of CBD to nutritional supplementation by forearm grip strength tests and by the short physical performance battery test
5. Muscle volume and qualitative muscle analysis by calculation of the muscle mass index at the level of the 3rd lumbar vertebra by CT method and evaluation of lean mass and muscle mass by impedancemetric technique before panendoscopy and at the end of the addition of CBD to nutritional supplementation
6. Measurement of systemic inflammation by calculating the systemic inflammatory response index
7. Measurement of tumor evolution between panendoscopy and stopping the addition of CBD to nutritional supplementation by CT method according to RECIST 4.1 criteria

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Of Clermont-Ferrand

Sponsor organisation

University Hospital Of Clermont-Ferrand

Address

58 Rue Montalembert

City

Clermont Ferrand Cedex 1

Postcode

63003

Country

France

Scientific contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Public contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications