30 Participants Needed

Cannabidiol for Neuropathy in Colorectal Cancer

NV
HV
Overseen ByHenkel Valentine, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

NV

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

I can take care of myself and perform daily activities.
I have never been treated with platinum-based chemotherapy.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

12 weeks
Every 2-3 weeks per chemotherapy cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of neuropathy symptoms and safety monitoring.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cannabidiol (CBD)
Trial Overview The study tests if CBD can prevent nerve damage caused by oxaliplatin in colorectal cancer patients. It's a pilot study where participants either receive CBD capsules plus standard therapy or just the standard therapy.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Cannabidiol (CBD)Experimental Treatment2 Interventions
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials
236
Recruited
39,300+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Combination CBD/THC in the management of ...Follow-up studies showed that CBD was also effective against oxaliplatin-associated mechanical sensitivity and synergized when co-administered with THC (9).
Safety and efficacy of cannabidiol in the management ...Cannabidiol (CBD) has been shown to attenuate CIPN in rodent models although its ability to reduce CIPN symptoms in humans is unexplored.
Neuroprotective Potential of Cannabidiol (CBD) in ...This is a pilot, prospective, randomized study evaluating the feasibility and acceptability of incorporating hemp-derived cannabidiol (CBD) ...
Comparative Effects of THC and CBD on Chemotherapy ...Our results showed an improvement in all symptoms after six months of uninterrupted cannabis consumption, as well as an overall improvement in ADL and QOL in ...
Cannabidiol for Preventing Oxaliplatin Induced Neuropathy ...Giving hemp-based CBD during Ox-based chemotherapy may be safe, tolerable, and/or effective in preventing OIPN in patients with locally advanced unresectable or ...
NCT07016971 | CBG/CBD Oil for Chemotherapy-Induced ...The goal of this clinical trial is to learn if a commercially available cannabigerol (CBG)/cannabidiol (CBD) oil is safe, feasible to use, and can help reduce ...
Phytocannabinoids for Reducing Chronic Chemotherapy ...Phytocannabinoids may be effective in reducing chronic chemotherapy-induced peripheral neuropathy symptoms in patients treated for breast or colon cancer.
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