Phytocannabinoids for Chemotherapy-Induced Neuropathy in Cancer Survivors

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Neuropathic agents, Alternative medicines

Disqualifiers: Active treatment, Liver cirrhosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

120 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{1 2 3 4 5}

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

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

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

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

Group I: Arm II (THC:CBD) Experimental Treatment 5 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 Treatment 3 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 Group 3 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.

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

1. England pubmed.ncbi.nlm.nih.gov

Synthetic peripherally-restricted cannabinoid suppresses chemotherapy-induced peripheral neuropathy pain symptoms by CB1 receptor activation. [2019]

2. China pubmed.ncbi.nlm.nih.gov

Modulating the endocannabinoid pathway as treatment for peripheral neuropathic pain: a selected review of preclinical studies. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Cannabinoids and Cancer Chemotherapy-Associated Adverse Effects. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Oral cannabidiol for prevention of acute and transient chemotherapy-induced peripheral neuropathy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Inhibition of anandamide hydrolysis attenuates nociceptor sensitization in a murine model of chemotherapy-induced peripheral neuropathy. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Topical Cannabinoids for Treating Chemotherapy-Induced Neuropathy: A Case Series. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled, crossover pilot trial with extension using an oral mucosal cannabinoid extract for treatment of chemotherapy-induced neuropathic pain. [2022]