Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People of any gender, aged 18 to 80, who have previously received chemotherapy for cancer and are now in remission
• People who have been diagnosed with chemotherapy-induced peripheral neuropathy (nerve damage caused by cancer treatment) with at least moderate symptoms — including pain and heightened sensitivity — that have been present for 3 months or more, and have been stable for at least 8 weeks before the screening visit
• People whose daily pain levels fall within a specific moderate range (a score of 4 to 8 out of 10) on a standard pain scale, recorded on at least 4 days during an initial diary period
• People who are generally well enough to carry out everyday activities, with minimal or no limitations on normal activity (as assessed by a standard health performance scale)
• People who are able to apply a gel to the affected skin area(s) themselves
• People who are able to understand the trial, communicate with the research team, and follow all trial requirements throughout
• People who agree to use only paracetamol as a rescue pain medication during the trial
• People willing to give written consent after reading the consent form and having the chance to discuss the trial with the research team
• People who agree to follow the trial's contraception requirements
• People who agree not to donate blood or blood products during the trial and for up to 3 months after receiving the trial medication

Who may not be able to join:

• Women who are pregnant, breastfeeding, or who are premenopausal, sexually active, and not using a reliable form of contraception
• People who have other painful conditions unrelated to chemotherapy-induced nerve damage (such as frequent headaches) that require paracetamol or anti-inflammatory medicines more than twice a week
• People who have nerve damage caused by something other than chemotherapy — for example, due to diabetes, alcohol use, inherited conditions, or autoimmune conditions
• People whose pre-trial health checks — including physical examination, heart tracing (ECG), or blood tests — show abnormal results that could affect the trial or pose a safety risk
• People with significant medical conditions (such as diabetes, seizure disorders, or psychological conditions) that could interfere with study procedures or pose added risk
• People who have had a stroke, heart attack, or blood clot in the lungs within the past 3 months
• People with significant psychiatric conditions, including severe depression, dementia, bipolar disorder, or schizophrenia
• People with a history of a suicide attempt, or who have had thoughts of suicide in the past 6 months
• People with a current active infection or a serious infection in the 30 days before the screening visit
• People with damaged, tattooed, or diseased skin, active skin conditions, infection, or significant skin redness at the area where the gel would be applied
• People with a history of severe allergic or adverse reactions to any medication, or known sensitivity to any ingredient in the trial gel
• People who have taken part in a skin irritation or sensitisation study in the 30 days before the first dose
• People who have certain bleeding conditions or who take blood-thinning medicines (relevant only if a skin biopsy is required — confirm with trial site)
• People who have taken part in another clinical trial in the 3 months before the first dose, or who are still in the follow-up period of another trial at the time of screening
• People who have used capsaicin-based pain relief products (including certain patches) in the 3 months before screening
• People who have used opioid (opiate) pain medicines in the 28 days before screening
• People who have used certain pain medicines — including anti-inflammatory drugs, aspirin-based products, topical pain-relief gels or patches, local anaesthetics (except before a skin biopsy), steroids, or nerve stimulation devices — from 14 days before the diary period begins until the final study visit
• People who are scheduled to receive radiation therapy or chemotherapy during the trial
• People whose blood pressure or heart rate at the screening visit falls outside the acceptable ranges set by the trial (a repeat measurement is permitted — confirm with trial site)
• People whose heart electrical activity reading (a specific heart rhythm measurement) is above the acceptable threshold at screening (a repeat measurement is permitted — confirm with trial site)
• People who test positive for hepatitis B, hepatitis C, or HIV
• People with a history of drug or alcohol misuse in the past 10 years, who regularly drink more than 14 units of alcohol per week, smoke more than 10 cigarettes a day, or make heavy use of e-cigarettes or vapes
• People whose urine test shows evidence of drug use
• People who complete fewer than 5 days of the 7-day initial pain diary
• People whose general practitioner (GP) objects to their participation on medical grounds
• People who are considered unlikely to be able to follow the trial's requirements

Important: Always verify eligibility with the trial site directly before applying.