Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breas
This phase II trials evaluates how well different types of phytocannabinoids (cannabidiol \[CBD\] versus tetrahydrocannabinol \[THC\] and CBD formulation \[THC:CBD\]) work to reduce chronic chemotherapy-induced peripheral neuropathy among breast and colon cancer survivors. Chemotherapy induced peripheral neuropathy is
| Condition(s) | Breast Carcinoma, Chemotherapy-Induced Peripheral Neuropathy, Colon Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This phase II trials evaluates how well different types of phytocannabinoids (cannabidiol \[CBD\] versus tetrahydrocannabinol \[THC\] and CBD formulation \[THC:CBD\]) work to reduce chronic chemotherapy-induced peripheral neuropathy among breast and colon cancer survivors. Chemotherapy induced peripheral neuropathy is a set of symptoms that includes pain, tingling, numbness and motor weakness caused by certain types of chemotherapy treatment. Phytocannabinoids are compounds made by the cannabis plant, such as THC and CBD, that have been found to be an effective treatment for chronic pain. Phytocannabinoids may be effective in reducing chronic chemotherapy-induced peripheral neuropathy symptoms in patients treated for breast or colon cancer. |
| Who can participate | Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Willingness to comply with all study interventions including the use of medical cannabis and follow-up assessments * Age: ≥ 18 years * Eastern Cooperative Oncology Group Performance Status Scale (ECOG) score ≤ 2 * Ability to read and understand English for questionnaires * Patients must have either neuropathy ≥ 1 according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 scale or a neuropathy score of \> 3 on a 0- |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | City of Hope Medical Center |
| Locations | Duarte, California, United States; Irvine, California, United States |
| Start date | 2025-10-03 |
| NCT ID | NCT06731894 |
| Official listing | https://clinicaltrials.gov/study/NCT06731894 |