Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BELCANTO)
The BELCANTO study is a research trial exploring whether a cannabis extract, called Avextra 10/10 Solution, can improve the quality of life for people with cancer who are also receiving palliative care. Palliative care focuses on providing comfort and support for symptoms. The study will compare how cannabis extract affects symptoms and overall well-being compared to a placebo (a dummy treatment) over about 12 days. Researchers will be looking at changes in everyday symptoms, pain levels, sleep quality, and general well-being. This type of study, known as a Phase II trial, helps us understand if a new treatment shows promise and is safe enough to study further.
At a glance
What is this study about?
This research study, called BELCANTO, is looking into whether a specific cannabis extract can help improve the quality of life for cancer patients. When we talk about 'quality of life' in this study, we mean how well you feel overall, including your physical comfort, sleep, and emotional well-being. The study specifically focuses on patients who are receiving 'palliative care,' which is a type of care that aims to provide comfort and improve life for people facing serious illnesses, rather than trying to cure the illness itself. The main goal is to see if cannabis extract can make a real difference in how patients experience their symptoms and feel day-to-day.
The study involves comparing two groups: one group will receive the cannabis extract, and the other will receive a 'placebo.' A placebo is a treatment that looks exactly like the real medication but doesn't contain any active ingredients. This comparison is really important because it helps the researchers figure out if any changes in symptoms are truly due to the cannabis extract or if they might be due to other factors, like the expectation of feeling better (which is called the 'placebo effect').
Over approximately 12 days, the research team will carefully track various things like your general symptoms, how much pain you're experiencing, your sleep patterns, and your overall sense of distress. They will also look at whether there are any changes in the amount of pain medication you might be taking. The information gathered will help determine if the cannabis extract could be a helpful option in palliative care to make patients more comfortable.
Key takeaways
- This study explores cannabis extract for quality of life in cancer patients.
- It focuses on improving comfort and symptoms in palliative care.
- The study compares cannabis extract to a placebo (dummy treatment).
- It lasts about 12 days, assessing changes in symptoms, pain, and sleep.
- Participation is voluntary, and you can withdraw at any time.
- Researchers will monitor for any potential benefits and side effects.
Who may be eligible?
To be able to take part in this study, you need to be an adult, aged 18 or over. This study is open to both men and women.
More detailed information about your specific health condition and other medications you might be taking will be checked by the study doctor to make sure this trial is safe and suitable for you. This is a very common and important step in all clinical trials to protect your health and ensure the study results are as accurate as possible.
If you are interested, the first step is to talk to your doctor or the study team. They will go through all the requirements with you and answer any questions you have to help you decide if this study is right for you.
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?
- Do you have a cancer diagnosis?
- Are you currently receiving palliative care?
- Are you prepared to attend appointments for approximately 12 days of treatment and follow-up?
- Are you comfortable with the possibility of receiving either the cannabis extract or a placebo?
What does participation involve?
If you decide to take part, you would receive either the cannabis extract or a placebo over approximately 12 days. You'll likely have regular appointments at the study clinic where the research team will ask you questions about your symptoms, pain, sleep, and how you're feeling overall. They will use special questionnaires and scales to keep track of these changes. You may also have some blood tests. The study will involve a comparison of how your symptoms change from the beginning of the study, known as 'baseline,' to the end of the 12-day period. Further follow-up assessments might also occur to see how you are doing over time. The exact number of visits and tests will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is the main goal of this study?
The main goal is to see if a cannabis extract can improve the quality of life and reduce symptoms for cancer patients receiving palliative care.
What is 'palliative care'?
Palliative care focuses on providing comfort, support, and improving quality of life for people with serious illnesses, rather than trying to cure the illness.
What is a 'placebo'?
A placebo is a sham treatment that looks like the real medication but contains no active ingredients. It helps researchers compare effects.
How long does treatment last in the study?
The study treatment period is approximately 12 days.
Will I know if I'm getting the cannabis extract or the placebo?
In a study like this, usually neither you nor the study doctors will know who is getting which treatment until the study is over. This is to ensure fair and accurate results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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