ACTION

• Research type

  Research Study

• Full title

  A Phase II randomised cross-over trial of orAl Cannabinoid versus placebo in the Treatment of chemotherapy Induced peripheral neurOpathic paiN (ACTION)

• IRAS ID

  1012593

• Contact name

  Marie Fallon

• Contact email

  marie.fallon@ed.ac.uk

• Sponsor organisation

  University of Edinburgh

• ISRCTN Number

  ISRCTN15275553

• Research summary

  One in 3 people will have cancer in their lifetime and many will be treated using treatments such as Chemotherapy. One harmful side effect of these treatments is that they can damage the nerves in the body. This is called Chemotherapy Induced Peripheral Neuropathy (CIPN). CIPN is very common, can affect up to 90% of patients and causes long-term pain in up to half of patients. This leads to problems carrying out normal day to day activities and affects their quality of life. CIPN is hard to treat with current medicines.
  We want to improve pain levels in CIPN patients. Laboratory work and early studies in patients has shown that substances found in the Cannabis sativa plant called cannabinoids (CBDs) can help with nerve pain like that seen in CIPN. As there hasn’t been much research using CBDs in CIPN, our study will test CBD. We also want to include in our study tests which look at what happens in the pain and mood systems in the brain when you take CBD. We can measure the different CBDs in the blood before and after treatment and look at the effects on the patient’s own natural CBD system.
  Patients will answer questions that measure their CIPN symptoms, questions about their quality of life, and ask if they are worried and depressed. We will take blood samples to measure the body’s natural CBD levels and perform a brain scan in patients using a machine called an MRI scanner. Patients will be split into one of two groups, taking either drug or placebo for 5 weeks, then switching to the other treatment for another 5 weeks. After 5 weeks, the study tests will be repeated and the patient will not take treatment for 2 weeks (a 'washout' period). At the end of the study, we will look at the effects of the treatment on pain relief, quality of life, physical function, the brain and mood. This work is important as it will tell us if a larger study is needed to show that CBDs are an effective treatment for CIPN, and how the study should be done.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  25/ES/0092

• Date of REC Opinion

  26 Nov 2025

• REC opinion

  Further Information Favourable Opinion