AuthorisedTherapeutic exploratory (Phase II)Interventional

Cannabis extrAct in oncology Patients for the treatment of TUmor Related symptom burden (CAPTURE)

This research study, called CAPTURE, is exploring if a cannabis extract called Avextra 10/10 Solution can help reduce the overall burden of symptoms for people with advanced cancer. These patients are currently using strong pain medications and other treatments. The study aims to see if the cannabis extract is better at easing symptoms compared to a 'dummy' oil solution that looks and feels the same but contains no active medicine. Researchers will be carefully monitoring how patients feel and their general well-being throughout the study to understand if this new treatment could make a difference.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Enrolment target

156

Start

21 Aug 2025

Patients with advanced oncologic disease receiving active treatment with WHO level II or III opioids and adjuvants therapies

What is this study about?

This study, called CAPTURE, is looking into whether a specific cannabis-based medicine could help people with advanced cancer feel better. We know that cancer and its treatments can cause many difficult symptoms, and researchers are always looking for new ways to help ease this burden. This particular study is focusing on an extract from the cannabis plant called Avextra 10/10 Solution.

The main aim of the study is to see if this cannabis extract can reduce the overall impact of symptoms that patients experience. This means looking at things like pain, tiredness, sickness, and other general discomforts. To make sure the results are fair, some patients will receive the actual cannabis medicine, while others will receive a 'placebo' – this is a dummy oil solution that looks and tastes exactly the same but doesn't contain any active medicine. This allows researchers to compare the effects of the real medicine versus no medicine at all.

Researchers will be carefully tracking how patients feel over several weeks using questionnaires that ask about their symptoms. They will also look at other important things like sleep quality, nutritional health, and any nerve pain. The information gathered from this study will help us understand if this cannabis extract could be a useful new option to help manage symptoms for people living with advanced cancer.

Key takeaways

The study explores a cannabis extract (Avextra 10/10) for cancer symptom relief.
It aims to reduce overall symptom burden in advanced cancer patients.
Patients are already on strong pain medication and other treatments.
Some patients will receive the cannabis extract, others a dummy oil (placebo).
Symptoms like pain, tiredness, and sleep quality will be carefully monitored.
The main assessment period for symptoms is expected to be 8 weeks.

Who may be eligible?

This study is designed for adults aged 18 years and older, with no upper age limit, who have advanced cancer. Both men and women can take part.

You would need to be currently receiving treatment for your cancer, and also be taking strong pain relief, specifically what doctors call WHO level II or III opioids, along with other supporting medicines.

There will be other detailed medical checks to make sure the study is safe and suitable for you, but generally, if you fit these main criteria, you might be able to join.

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 over?
Do you have advanced cancer?
Are you currently receiving active cancer treatment?
Are you taking strong pain relief medicines (WHO level II or III opioids)?
Are you taking other supporting medicines for your cancer symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given either the cannabis extract or a matching dummy oil solution to take by mouth. Both are oils. You would take this medicine at home, storing it carefully below 25°C and away from light, just like any other medicine.

Throughout the study, you would have regular appointments to see the study team. They will ask you to fill out questionnaires about how you are feeling, your symptoms, your sleep, and other aspects of your health. These questionnaires help the doctors understand if the treatment is working. We don't have details on the exact number of visits or the total length of the study from the provided information, but the main assessment period will be 8 weeks. Your doctor or the study team will provide precise details.

Potential risks and benefits

Taking part in a study is a big decision. Potential benefits might include a reduction in your symptoms or an improved sense of well-being, though this is not guaranteed as you might receive the placebo. There are potential risks associated with any new medicine, and while the cannabis extract is being studied for its safety, side effects could occur. The study team will explain all known or potential risks in detail. Remember, 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
Italy

Common questions

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks, tastes, and feels exactly like the real medicine but does not contain any active ingredients. It's used to compare the effects of the actual medicine fairly.

What kind of cancer patients are included?

This study is for patients with advanced cancer who are already receiving active treatment and taking strong pain relief medicines (WHO level II or III opioids) along with other supportive treatments.

How will my symptoms be measured?

Your symptoms will be measured using questionnaires, including one called ESAS, which asks about things like pain, tiredness, sickness, and overall well-being. Other questionnaires will look at sleep, nutrition, and nerve pain.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know whether you're receiving the active cannabis extract or the placebo during the study. This is called 'blinding' and helps ensure the study results are as unbiased as possible.

How long will I take part in the study?

The main assessment period for your symptoms is planned for 8 weeks, but the total duration of your participation in the study, including follow-ups, will be explained by the study team.