Cannabidiol for Neuropathy in Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether cannabidiol (CBD), a compound from hemp, can help prevent nerve pain in individuals undergoing chemotherapy for colorectal cancer. Participants will receive either CBD with their usual cancer treatment or just the usual treatment. The researchers aim to determine if adding CBD makes chemotherapy more tolerable by reducing the risk of nerve problems. This trial may suit someone with advanced colorectal cancer who is about to begin a specific chemotherapy regimen and has no current nerve issues. As an Early Phase 1 trial, this research focuses on understanding how CBD works in people, offering participants the opportunity to explore its potential benefits.
Do I have to stop taking my current medications for the trial?
You may need to stop certain medications before joining the trial, especially if you are using medical cannabis or medications that are contraindicated with CBD, like some anti-seizure or anti-psychotic drugs. It's best to discuss your current medications with the trial team to see if any changes are needed.
Is there any evidence suggesting that cannabidiol (CBD) is likely to be safe for humans?
Research has shown that cannabidiol (CBD) may help manage symptoms of nerve damage caused by chemotherapy. One study found that taking 135 mg of CBD daily alleviated some symptoms without causing serious side effects. While these results are promising, it's important to note that this research remains in the early stages.
CBD is usually well-tolerated, but like any treatment, it can have side effects. These might include fatigue, diarrhea, or changes in appetite, with serious side effects appearing to be rare. Since this study is in an early phase, it primarily aims to assess how well patients tolerate CBD and identify any potential safety issues. Those considering joining the trial should consult their healthcare provider if they have concerns.12345Why do researchers think this study treatment might be promising?
Researchers are excited about cannabidiol (CBD) for neuropathy in colorectal cancer because it offers a novel approach to pain management. Unlike the standard chemotherapy treatments, which primarily focus on attacking cancer cells, CBD is derived from hemp and can potentially alleviate neuropathic pain by interacting with the body's endocannabinoid system. This unique mechanism might provide relief with fewer side effects than traditional pain medications, which often include opioids or other analgesics. Additionally, CBD could enhance the quality of life for patients undergoing chemotherapy by addressing pain and discomfort more effectively.
What evidence suggests that cannabidiol might be an effective treatment for neuropathy in colorectal cancer?
Research suggests that cannabidiol (CBD) might help with nerve pain caused by chemotherapy, such as oxaliplatin-induced peripheral neuropathy (OIPN). In animal studies, CBD has shown promise in easing nerve pain symptoms, but its effects on humans remain unclear. Some studies have found that CBD can reduce sensitivity to touch, a common issue in nerve pain. In this trial, one group of participants will receive hemp-derived CBD capsules alongside standard oxaliplatin-based chemotherapy to evaluate potential benefits. Early findings indicate that CBD might be safe and tolerable for patients undergoing chemotherapy, which is encouraging for its potential use in preventing nerve pain.12567
Who Is on the Research Team?
Namrata Vijayvergia, MD
Principal Investigator
Fox Chase Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced colorectal cancer who are about to start or have had one cycle of oxaliplatin-based chemotherapy. They should not have prior platinum treatment, existing neuropathy, or liver function beyond set limits. Participants must understand and consent to the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive hemp-derived CBD capsules in addition to standard oxaliplatin-based chemotherapy or standard therapy alone. CBD is administered at a dose of 150 mg orally twice daily, starting the day before oxaliplatin and continuing through 7 days after each chemotherapy cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of neuropathy symptoms and safety monitoring.
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol (CBD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fox Chase Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator