Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
If you've had chemotherapy, you might have experienced nerve pain called CIPN. This study is looking at a new skin gel, VMD-3866, that doesn't contain opioids or strong painkillers you usually swallow. Doctors want to see if this gel can make your nerve pain better and if it's safe to use. The gel is designed to work where you apply it, with very little getting into your bloodstream or brain. You'd be trying either the study gel or a dummy gel, and telling researchers about your pain. This is an important step to find new ways to help people with CIPN.
At a glance
What is this study about?
Many people who have had chemotherapy treatments for cancer unfortunately develop nerve damage that causes pain, tingling, or numbness, particularly in their hands and feet. This is called Chemotherapy-Induced Peripheral Neuropathy, or CIPN for short. Currently, the treatments available for this pain don't always work well for everyone.
This study is looking into a new treatment called VMD-3866. It's a gel that you rub on your skin. The idea behind this gel is that it gently calms down overactive nerves under the skin that are causing the pain. Because it's a gel applied to the skin, very little of the medicine is expected to get into your bloodstream or affect your brain. This means it's unlikely to be addictive or interfere with other medications you might be taking.
The main goal of this study is to see if VMD-3866 gel can reduce the pain associated with CIPN and to understand if there are any side effects. Researchers will compare VMD-3866 to a 'placebo gel' – which looks exactly the same but doesn't contain any active medicine – to understand if the new gel is truly effective.
Key takeaways
- This study tests a new skin gel for nerve pain (CIPN) caused by chemotherapy.
- The gel, VMD-3866, aims to reduce pain by acting on nerves in the skin.
- Participants will use either the active gel or a dummy gel.
- The study looks for pain relief and any potential side effects.
- Participation involves clinic visits, home application of gel, and pain diary entries.
Who may be eligible?
This study is looking for adults aged 18 to 80 who have pain from chemotherapy-induced nerve damage (CIPN). You need to have finished your chemotherapy, be in remission, and have had this nerve pain for at least three months, with the pain being quite steady for the last eight weeks. Your pain should be in the moderate range when measured.
There are also some things that would mean you couldn't join. For example, if you are pregnant, breastfeeding, or could become pregnant and aren't using reliable contraception. You also can't join if you have other conditions that cause nerve pain, or severe pain unrelated to CIPN, or skin problems where you have the nerve pain, as these could make it harder to properly assess the study gel's effects.
- Are you 18-80 years old?
- Have you finished chemotherapy and are in remission?
- Do you have moderate nerve pain (CIPN) that's been stable for at least 8 weeks?
- Are you able to follow study instructions and apply the gel yourself?
- Are you able to use paracetamol as your only pain relief for sudden pain during the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, it will involve two main treatment periods. In one period, you'll use the VMD-3866 gel, and in the other, you'll use a dummy gel (placebo). You won't know which gel you're using at any time – this helps the researchers see if the real gel truly makes a difference. Each treatment period lasts about 8 days, and there will be at least a 7-day break between them.
Before each treatment period, you'll record your pain levels for 7 days in a diary. You'll continue to do this during the treatment periods, about an hour after each dose. You'll visit the study clinic for your first and last doses in each period. For all other doses, you'll apply the gel yourself at home. Some participants will also have a skin sample taken (a biopsy) and sensory tests, both at the start and end of each treatment period. After your last dose, there will be a follow-up phone call to check in how you are doing.
Potential risks and benefits
Locations (1)
- Hammersmith Medicines Research Ltd (HMR code 24-503)London, United Kingdom· Recruiting
Common questions
What is CIPN?
CIPN is pain, tingling, or numbness in your hands and feet caused by damage to your nerves from certain chemotherapy drugs.
What is VMD-3866 gel?
It's a new experimental gel applied to the skin, designed to calm down overactive nerves and reduce pain from CIPN.
Will I know if I'm getting the real gel or the dummy gel?
No, neither you nor the study team will know which gel you are using during the study. This helps ensure fair results.
How often will I need to visit the clinic?
You'll visit the clinic for your first and last doses of gel in each of the two treatment periods. Other doses are applied at home.
Can I still take my regular painkillers?
During the study, you'll only be able to take paracetamol for sudden pain if you need it.
How to find out more
Jay Wu, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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