Phytocannabinoids for Chemotherapy-Induced Neuropathy in Cancer Survivors
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you do not start any new medications for chemotherapy-induced neuropathy during the study, and you must be on stable doses of your current medications for at least 4 weeks before joining. If you are using medical cannabis or other alternative medicines, you will need to stop those before participating.
What data supports the effectiveness of the drug Phytocannabinoids for treating chemotherapy-induced neuropathy in cancer survivors?
Research shows that cannabinoids, which are compounds found in cannabis, can help reduce pain from chemotherapy-induced neuropathy by activating certain receptors in the body. Studies in animals have demonstrated that these compounds can effectively manage pain without causing significant side effects.12345
Is the use of phytocannabinoids generally safe for humans?
Cannabinoids, including those derived from plants, have been used for managing cancer treatment side effects like pain and nausea, and two cannabis-based drugs are FDA-approved for such uses. While cannabinoids can effectively reduce pain from chemotherapy-induced neuropathy, their use is sometimes limited by side effects related to the central nervous system, although some synthetic versions have been developed to minimize these issues.13467
How do phytocannabinoids differ from other drugs for chemotherapy-induced neuropathy?
Phytocannabinoids are unique because they target the endocannabinoid system, potentially reducing pain without the central nervous system side effects common in other treatments. Unlike traditional pain medications, they may work by activating specific cannabinoid receptors (CB1 and CB2) to alleviate symptoms of chemotherapy-induced neuropathy.12345
What is the purpose of this trial?
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.
Research Team
Richard T. Lee
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for breast and colon cancer survivors who are experiencing chronic pain, tingling, numbness, or weakness due to chemotherapy-induced peripheral neuropathy. Participants must have completed chemotherapy at least 3 months prior to entering the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either CBD, THC:CBD, or placebo orally in a structured dosing schedule over two 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Phytocannabinoids
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator