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RecruitingPhase IIInterventional

A randomised trial to see if an oral cannabis-based medicine (CBD) can help to treat chemotherapy related nerve pain

This study is investigating if a medicine based on cannabis (CBD) can ease nerve pain that sometimes develops after chemotherapy for cancer. This type of pain, called Chemotherapy Induced Peripheral Neuropathy (CIPN), can affect many cancer patients and can be hard to treat with current medicines. This research aims to see if CBD could offer a new way to help reduce this pain and improve quality of life. We will also look at how CBD affects the brain and body's natural systems related to pain and mood. This study is an important step to see if a larger trial should be done to confirm if CBD is an effective treatment for CIPN.

At a glance

Status
Recruiting
Phase
Phase II
Sponsor
University of Edinburgh
Enrolment target
92
Start
18 May 2026
Estimated completion
31 Jan 2027

What is this study about?

Many people go through chemotherapy to treat cancer. While these treatments are very important, they can sometimes cause problems like nerve damage, which leads to pain. This pain is called Chemotherapy Induced Peripheral Neuropathy (CIPN). It can be quite common and sometimes lasts for a long time, making it hard to do daily activities and affecting how people feel overall. Unfortunately, our current medicines don't always work well to control this pain.

That's why we're doing this study. We want to see if a medicine made from the cannabis plant, specifically one called Cannabidiol (CBD), could help ease this nerve pain. Scientific studies in labs and early research with people have shown that CBD might be useful for nerve pain like CIPN. Since we don't have much research yet on CBD for CIPN, our study will help us learn more.

We're also interested in understanding how CBD works in the body and brain. We'll be looking at how it might affect your body's natural pain and mood systems. The results from this study will be really important. They will help us decide if we should do a bigger study in the future to confirm if CBD is a good treatment option for people with CIPN, and how best to carry out such a study.

Key takeaways

  • This study is testing if a cannabis-based medicine (CBD) can help nerve pain from chemotherapy.
  • Many cancer patients get this type of pain, and it can be hard to treat.
  • You will take either the CBD medicine or a dummy pill, and then switch to the other, for a total of 10 weeks of treatment.
  • Participation involves questionnaires, blood tests, and two brain scans.
  • The study aims to see if a larger trial is needed for CBD for CIPN.
  • Results might help future patients, even if you don't personally benefit.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have finished your chemotherapy treatment that caused nerve damage at least three months ago, and your nerve pain (CIPN) should have been stable for at least six weeks, meaning it hasn't changed much recently.

There are also some specific pain levels we're looking for to ensure the treatment has something to work on. You also need to be willing to give written permission to take part and agree not to use any other cannabis products during the study. If you're a woman who could become pregnant, or a man whose partner could become pregnant, you'll need to use reliable contraception during and shortly after the study. Also, you must be able to have an MRI scan.

We cannot include you if your pain medications have changed in the last month, or if you've had any other treatments recently that might affect your CIPN. We also can't include you if you're taking part in another drug trial at the same time.

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.

  1. Are you 18 years old or older?
  2. Did you finish your key chemotherapy treatment at least 3 months ago?
  3. Has your nerve pain (CIPN) been stable for at least 6 weeks?
  4. Are you willing to avoid other cannabis products during the study?
  5. Can you use reliable contraception if you or your partner could become pregnant?
  6. Are you able to have an MRI scan?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several steps. You'll answer questions about your nerve pain, your quality of life, and how you're feeling emotionally. We'll also take blood samples to check your body's natural CBD levels. You will have two brain scans using an MRI machine at the Royal Infirmary of Edinburgh – one at the start and one after five weeks of treatment.

You'll be randomly put into one of two groups. One group will take the CBD medicine for five weeks, and the other will take a dummy pill (placebo) for five weeks. After this first period, you'll have a two-week break where you don't take any medicine (this is called a 'washout' period). Then, you'll switch over to the other treatment for another five weeks. So, everyone in the study will have a chance to take both the real medicine and the dummy pill at different times.

Throughout the study, nurses will be there to support you and make sure you are safe. After all the treatment periods and assessments, we will look at how the medicine affected your pain, quality of life, physical abilities, brain function, and mood. The total duration of your active participation, including treatment and follow-up, will be around 12 weeks.

Potential risks and benefits

You might or might not feel a direct benefit from taking the study medicine. However, even if you don't personally benefit, the information we gather from your participation could help other patients with similar conditions in the future by improving their care. Please know that if the study medicine is later developed into a commercial product, you won't receive any financial reward. Possible side effects from CBD can include changes in weight, stomach upset like diarrhoea or nausea, urine infections, changes in liver test results, fever, cough, rash, feeling irritable, or rarely, feeling low or having thoughts of self-harm. These are not common, and our nurses will closely monitor your safety. You won't be able to join other drug trials while participating in this one. If any unusual results show up on your blood tests or MRI scans, our team will follow up on them and tell you and your GP. Attending appointments, answering questions, and having blood tests or MRI scans can sometimes be tiring or uncomfortable, for example, minor bruising from blood tests or feeling enclosed in the MRI scanner. We try to keep these to a minimum, and our team will guide you through everything.

Locations (2)

  • Western General Hospital
    City only
    Lothian, Scotland
  • NHS Lothian
    Approximate
    Edinburgh, Scotland

Common questions

What is CIPN?

CIPN is nerve pain that can happen after chemotherapy treatment for cancer.

What is CBD?

CBD is a substance from the cannabis plant that is being studied to see if it can help with pain. It's not the part of cannabis that makes you feel 'high'.

Will I know if I'm getting the CBD or a dummy pill?

No, you won't know which one you're taking at any given time. This helps us get accurate results about the medicine's effect.

Where is the study taking place?

The study is based at the University of Edinburgh in the UK. MRI scans will be done at the Royal Infirmary of Edinburgh.

How long will the study last for me?

Your active participation, including taking the medicine and having tests, will be around 12 weeks.

How to find out more

Emma Ward

Always speak to your GP or specialist before deciding to take part in a study.

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