AuthorisedTherapeutic exploratory (Phase II)Interventional

PANACEA : Effect of PrehAbilitation by NutritionAl supplementation with Cannabidiol on skeletal muscle mass and mitochondrial function in hEad and neck cAncer : a proof of concept controlled randomized trial

This study, called PANACEA, is exploring whether a special nutritional supplement, which includes a cannabis-derived ingredient (CBD), can help people with head and neck cancer. The main goal is to see if this supplement can improve muscle health and how well their cells produce energy. Researchers will compare those who receive the supplement with those who get a dummy treatment (placebo). This is a Phase II 'proof of concept' study, meaning it's an early step to find out if this approach is safe and effective enough to study further. It's for adults aged 18 and over, of any gender. The study aims to understand if this nutritional support can combat muscle weakness often seen in cancer patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

University Hospital Of Clermont-Ferrand

Enrolment target

Start

16 Sep 2025

Head and Neck Cancer

What is this study about?

When you have cancer, especially head and neck cancer, your body can go through a lot of stress. This can sometimes lead to muscle loss and feeling very tired, as your body's energy-producing parts in the cells (called mitochondria) might not work as well. This study, called PANACEA, is looking into a new way to help. It's testing a special nutritional drink that includes a substance called cannabidiol, or CBD for short. CBD comes from the cannabis plant, but it's not the part that makes you feel 'high'. The researchers want to see if this nutritional support can help improve your muscle strength and how efficiently your cells make energy.

This is a 'Phase II' study, which means it's an early step to explore if this treatment idea is promising enough to continue researching on a larger scale. Participants will be split into two groups: one receiving the nutritional drink with CBD and another receiving a similar drink without CBD (a 'placebo'). This helps researchers fairly compare the effects. The main thing they'll be checking is if there's a significant change in how well your muscle cells produce energy between the start of the study and when you have surgery, or a consultation if surgery isn't planned.

Ultimately, the hope is that this kind of nutritional support could help people with head and neck cancer maintain their muscle health and energy levels, which can be really important for recovery and overall well-being. By understanding if and how this approach works, it could pave the way for better support strategies for cancer patients in the future.

Key takeaways

This study explores a nutritional supplement with CBD for head and neck cancer.
It aims to improve muscle health and cell energy production.
It's a 'Phase II' study, an early step to see if the idea is promising.
Participants will receive either the supplement or a placebo (dummy treatment).
Measurements include muscle strength, body scans, and tracking side effects.
Participation involves regular checks and reporting over a specific period.

Who may be eligible?

This study is looking for adult volunteers, aged 18 and older, who have been diagnosed with head and neck cancer. Both men and women are welcome to take part.

To be considered for this study, you will need to meet certain health requirements that the medical team will assess. These are important to ensure your safety and that the study results are clear.

If you have head and neck cancer and are interested, the first step is to discuss it with your doctor. They can help determine if this study might be a good fit for you based on your specific health situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with head and neck cancer?
Are you comfortable with taking a nutritional supplement daily?
Are you able to attend regular study appointments and tests?
Are you willing to share information about your health and habits?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given a nutritional supplement, either with CBD or a placebo (a dummy treatment). You would take this daily for a set period. Researchers will regularly check things like your appetite, any stomach upsets like nausea or vomiting, and how you feel generally. This involves daily reporting during the CBD period and for a week after stopping.

To see how the treatment affects your muscles, you'll have some tests before starting the supplement and again afterwards. These include measuring your grip strength and how well you can perform simple physical tasks. They'll also use scans (like CT scans) to measure your muscle volume and look at your body composition to see if your lean muscle mass has changed. Blood tests will be done to check for signs of inflammation.

Throughout the study, researchers will also keep an eye on your cancer's progress using CT scans. They will also ask about your smoking and alcohol habits. The total duration of your participation will depend on your treatment plan (e.g., if you have surgery or just consultations) and the schedule for taking the supplement and follow-up checks.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as receiving a new investigational treatment that might help your condition, and contributing to medical knowledge that could help others in the future. However, there are also potential risks; for example, the CBD supplement might cause side effects like changes in appetite or stomach issues, even if these are generally mild. As with any medication, individual reactions can vary, and there's no guarantee the treatment will be effective for you. You will be closely monitored by the medical team throughout, and it's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is CBD and why is it being used in this study?

CBD stands for cannabidiol, a natural substance found in the cannabis plant. It's being studied here because it might help with muscle health and energy production in cells, without causing the 'high' feeling associated with cannabis.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It's used to fairly compare the effects of the actual treatment.

Will I know if I'm getting CBD or the placebo?

No, this is a 'blinded' study, meaning neither you nor the study team will know which you are receiving. This helps ensure the results are unbiased.

What kind of tests will I have?

You'll have physical tests like grip strength, scans to measure your muscles, and blood tests. You'll also be asked to report daily on your appetite and any stomach problems.

How long will I be in the study?

The exact length depends on your individual treatment plan for your cancer and the study schedule, but it will involve taking the supplement for a period and then follow-up checks.