Cannabidiol for Head and neck squamous cell carcinoma | Head and Neck Cancer

Inclusion criteria

• {"criterion_text":"- 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)"}
• {"criterion_text":"- Stage 2 or 3 nutritional risk according to the classification specific to this study (light to moderate nutritional risk)"}
• {"criterion_text":"- Consent to participate in the study"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- To have of a means of communication (mobile phone) to monitor tolerance and appetite while taking CBD"}

Exclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Addiction to other drugs or cannabis"}
• {"criterion_text":"- Pregnant and breastfeeding women"}
• {"criterion_text":"- Persons under curatorship, guardianship, protection of justice or deprived of liberty"}
• {"criterion_text":"- Age <18 years"}
• {"criterion_text":"- History of chemotherapy or radiotherapy for head and neck cancer"}
• {"criterion_text":"- Malnutrition prior to the onset of head and neck cancer"}
• {"criterion_text":"- Morbid obesity"}
• {"criterion_text":"- Absence of nutritional risk (grade 1) or severe nutritional risk requiring urgent renutrition (grade 4) during the nutritional assessment"}
• {"criterion_text":"- History of epilepsy"}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Change in muscle mitochondrial activity measured between panendoscopy and surgery (or consultation if no surgery); assessed as change in muscle mitochondrial activity perioperatively."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Daily measurement of appetite and presence of digestive disorders (notably nausea and vomiting) during the period CBD is added to nutritional supplementation."}
• {"endpoint_text":"- Présence de signes de sevrage et ou de manques au CBD dans les 7 jours suivant l’arrêt de la consommation de CBD","definition_or_measurement_approach":"Assessment of presence of withdrawal signs or cravings for CBD during the 7 days following cessation of CBD consumption."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Recording measures during first 3 days of CBD intake, then weekly during consumption, and daily for 7 days after stopping; includes daily recording of tobacco and alcohol consumption."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessment of muscular functional capacity by forearm grip strength tests and the short physical performance battery test performed before panendoscopy and after CBD addition to supplementation."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"CT-based calculation of muscle mass index at L3 and bioimpedance evaluation of lean and muscle mass before panendoscopy and after CBD supplementation period."}
• {"endpoint_text":"- Measurement of systemic inflammation by calculating the systemic inflammatory response index","definition_or_measurement_approach":"Measurement of systemic inflammation via calculation of the systemic inflammatory response index."}
• {"endpoint_text":"- Measurement of tumor evolution between panendoscopy and stopping the addition of CBD to nutritional supplementation by CT method according to RECIST 4.1 criteria","definition_or_measurement_approach":"Tumor evolution measured by CT according to RECIST 4.1 criteria between panendoscopy and the end of CBD supplementation."}

France

Earliest CTIS Part Ii Submission Date

21-07-2025

Latest Decision Or Authorization Date

30-01-2026

Processing Time Days

193

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

University Hospital Of Clermont-Ferrand

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France