120 Participants Needed

Phytocannabinoids for Chemotherapy-Induced Neuropathy in Cancer Survivors

Recruiting at 1 trial location
Prior Safety DataThis treatment has passed at least one previous human trial

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, M.D. | City of Hope ...

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

I agree to let my biopsy samples be used for this study.
I can take care of myself and am up and about more than half of my waking hours.
Documented informed consent of the participant and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines
See 9 more

Exclusion Criteria

I am not taking any strong medication that affects liver enzymes.
Previous medical cannabis use for any indication within 30 days of enrollment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either CBD, THC:CBD, or placebo orally in a structured dosing schedule over two 28-day cycles

8 weeks
Regular visits for monitoring and dose adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Phytocannabinoids
Trial Overview The study is testing the effectiveness of phytocannabinoids (CBD alone or a THC:CBD combination) in reducing symptoms of nerve damage caused by chemotherapy in breast and colon cancer survivors. It's a phase II trial that includes biospecimen collection and surveys.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm II (THC:CBD)Experimental Treatment5 Interventions
Patients receive THC:CBD PO QD on days 1-3 of cycle 1, BID on days 4-6 of cycle 1, and TID on days 7-28 of cycle 1. Patients receive THC:CBD PO TID on days 1-28 of cycle 2. Cycles repeat every 28 days for up to 2 cycles in the absence of unacceptable toxicity. Patients undergo urine collection during screening.
Group II: Arm I (CBD)Experimental Treatment3 Interventions
Patients receive CBD PO QD on days 1-3 of cycle 1, BID on days 4-6 of cycle 1, and TID on days 7-28 of cycle 1. Patients receive CBD PO TID on days 1-28 of cycle 2. Cycles repeat every 28 days for up to 2 cycles in the absence of unacceptable toxicity. Patients undergo urine collection during screening.
Group III: Arm III (placebo)Placebo Group3 Interventions
Patients receive placebo PO QD on days 1-3 of cycle 1, BID on days 4-6 of cycle 1, and TID on days 7-28 of cycle 1. Patients receive placebo PO TID on days 1-28 of cycle 2. Cycles repeat every 28 days for up to 2 cycles in the absence of unacceptable toxicity. Patients undergo urine collection during screening.

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

References

Synthetic peripherally-restricted cannabinoid suppresses chemotherapy-induced peripheral neuropathy pain symptoms by CB1 receptor activation. [2019]
Modulating the endocannabinoid pathway as treatment for peripheral neuropathic pain: a selected review of preclinical studies. [2018]
Cannabinoids and Cancer Chemotherapy-Associated Adverse Effects. [2022]
Oral cannabidiol for prevention of acute and transient chemotherapy-induced peripheral neuropathy. [2022]
Inhibition of anandamide hydrolysis attenuates nociceptor sensitization in a murine model of chemotherapy-induced peripheral neuropathy. [2018]
Topical Cannabinoids for Treating Chemotherapy-Induced Neuropathy: A Case Series. [2021]
A double-blind, placebo-controlled, crossover pilot trial with extension using an oral mucosal cannabinoid extract for treatment of chemotherapy-induced neuropathic pain. [2022]
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