Study of dronabinol and cannabidiol oral solution for symptom relief in advanced cancer patients receiving opioid treatment

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What is this study about?

This study focuses on managing symptoms in patients with advanced cancer who are receiving strong pain medications called opioids. The research examines how a combination of two cannabis-derived substances – dronabinol and cannabidiol (Cannabis Extract Avextra 10/10 Solution) – might help reduce various symptoms that cancer patients experience, such as pain, nausea, loss of appetite, and fatigue.

The purpose of this research is to evaluate if adding this cannabis extract solution to current pain treatment can improve overall symptom management compared to placebo. The medication being tested is taken by mouth as a liquid solution. Study participants will receive either the cannabis extract or placebo while continuing their regular pain medications.

The study will last 8 weeks, during which participants will be monitored for changes in their symptoms. The research team will assess various aspects of well-being, including sleep quality, appetite, energy levels, and pain intensity. This will help determine how effective the cannabis extract is at relieving multiple symptoms that cancer patients commonly experience.

1 Initial assessment and medication start

You will receive either Cannabis Extract Avextra 10/10 Solution or a placebo (inactive substance that looks the same)

The solution is taken by mouth

You will continue your current pain medications (opioids) and other treatments during the study

2 Treatment period

The treatment continues for 8 weeks

You will take the oral solution while maintaining your regular cancer treatment

Your symptoms will be monitored using various assessment tools:

– ESAS questionnaire to measure overall symptom burden

– Assessment of nutrition status

– Evaluation of sleep quality

– Assessment of nerve pain

– Measurement of fatigue levels

3 Storage requirements

Keep the medication in a tightly closed container

Store at temperature below 25°C

Protect from light

4 Final assessment

After 8 weeks, your symptoms will be evaluated again using the same questionnaires

The effectiveness of the treatment will be measured by comparing your symptom scores to the initial assessment

5 Safety requirements

If you are able to become pregnant, you must:

– Have a negative pregnancy test before starting

– Use two effective methods of birth control during the study

Who Can Join the Study?

Must provide written informed consent to participate in the study
Must be 18 years or older, any sex, gender, sexual orientation, and ethnicity
Must not have used cannabis in the past 6 months
Must have advanced cancer with a life expectancy of at least 6 months
Must be currently receiving active cancer treatment
Must have at least one of these symptoms:
- Physical symptoms like moderate to severe pain, nausea, vomiting, poor appetite, or fatigue
- Mental health symptoms like anxiety, depression, or difficulty sleeping
Must have a performance status (ability to perform daily activities) score of 3 or better
Must have a total symptom distress score of 16 or higher on the Edmonton Symptom Assessment System (a tool that measures different symptoms)
Must be taking stable doses of strong or moderate pain medications and/or other supportive medications
For women who can become pregnant:
- Must have a negative pregnancy test
- Must use two highly effective methods of birth control (with less than 1% chance of pregnancy)

Who Cannot Join the Study?

Known allergy or hypersensitivity to cannabis, THC, CBD, or any components of the study medication
History of severe psychiatric disorders (such as schizophrenia, severe depression, or severe anxiety disorders)
Significant heart conditions including unstable heart disease or recent heart attack
Liver dysfunction (serious problems with liver function)
Current or past substance use disorder including cannabis use disorder
Pregnant women or women who are breastfeeding
Using medications that could interact with cannabis-based products
Unable to provide informed consent
Participation in another clinical trial within the past 30 days
Unstable medical condition that could interfere with study participation
History of seizures or epilepsy
Severe kidney disease (problems with kidney function)
Unable to follow study procedures or attend scheduled visits
Current use of any form of cannabis or cannabis-derived products

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.09.2025

Trial locations

Investigated drugs:

Cannabis extract Avextra 10/10 is an oral solution containing balanced amounts of THC (tetrahydrocannabinol) and CBD (cannabidiol). It is derived from the cannabis plant and is being studied as an additional treatment for managing symptoms in cancer patients. This medication is designed to help reduce the overall symptom burden in patients who are already receiving strong pain medications (opioids) as part of their cancer treatment.

WHO level II and III opioids are strong pain medications commonly used to manage moderate to severe pain in cancer patients. These medications are part of the standard treatment that patients receive for pain management during their cancer care.

Investigated diseases:

Cancer pain

Advanced Cancer – A condition where cancer cells have spread beyond their original location to other parts of the body. The disease affects normal body functions and can cause various symptoms including pain, fatigue, and changes in appetite. As cancer progresses, it can impact multiple organ systems and lead to various physical complications. The condition often causes changes in the patient’s daily activities and quality of life. Patients may experience different symptoms depending on the type and location of cancer.

Chronic Cancer Pain – A persistent pain condition that occurs in cancer patients due to tumor growth, nerve compression, or other cancer-related factors. The pain can be constant or intermittent, varying in intensity throughout the day. Cancer pain can affect different parts of the body and may change in character over time. The condition can significantly impact sleep patterns and daily activities.

Cancer-related Sleep Disorders – A group of sleep disturbances that commonly occur in cancer patients, characterized by difficulty falling asleep, staying asleep, or getting restful sleep. These sleep problems can occur at any stage of cancer and may fluctuate in severity. The condition often accompanies other cancer-related symptoms and can affect daytime functioning.

Cancer-related Fatigue – A persistent feeling of physical, emotional, and mental tiredness related to cancer that is not relieved by rest. This fatigue differs from normal tiredness and can occur even after minimal activity. The condition can affect daily activities and social interactions. The intensity of fatigue may vary throughout the day and during different stages of cancer.

Trial ID:

2024-519568-42-00

Protocol code:

CAPTURE

Trial Phase:

Therapeutic exploratory (Phase II)

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