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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well certain compounds from the cannabis plant, such as CBD and THC (phytocannabinoids), can reduce symptoms like pain and tingling caused by chemotherapy in breast and colon cancer survivors. Participants will receive either CBD alone, a combination of THC and CBD, or a placebo to determine which is most effective. Ideal participants are those who have experienced these symptoms after chemotherapy with specific drugs, such as paclitaxel or cisplatin, and are no longer undergoing active cancer treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, CBD was found to be safe and alleviated symptoms of chemotherapy-induced peripheral neuropathy (CIPN) without causing serious side effects. Another study showed that CBD combined with exercise improved CIPN symptoms, suggesting it is well-tolerated.

Research indicates that the THC and CBD mix effectively reduces CIPN symptoms. Patients generally received the combination well, with higher THC doses showing better results. Though side effects can occur, they are usually mild.

Both treatments are in a mid-stage trial, meaning they have passed initial safety checks, but researchers are still assessing their safety and effectiveness. The existing use of CBD for other conditions supports its safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about phytocannabinoids, like CBD and THC:CBD combinations, for treating chemotherapy-induced neuropathy because they offer a natural alternative to traditional medications, which often include antidepressants, anticonvulsants, or opioids. Unlike these standard treatments, phytocannabinoids work by interacting with the body's endocannabinoid system, potentially offering pain relief without the heavy side effects linked to opioids. Additionally, these compounds may have anti-inflammatory properties, which could address the underlying causes of neuropathy rather than just masking the symptoms. This dual action of pain relief and inflammation reduction makes phytocannabinoids a promising option for those seeking less conventional, yet potentially effective, treatments.

What evidence suggests that this trial's treatments could be effective for chemotherapy-induced neuropathy?

This trial will evaluate the effects of different phytocannabinoid treatments on chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors. Participants in Arm I will receive cannabidiol (CBD). Studies have shown that CBD may reduce symptoms of CIPN, such as pain and tingling. Research indicates that taking 135 mg of CBD per day can lessen some CIPN symptoms without major side effects. Participants in Arm II will receive a combination of THC and CBD. Evidence suggests this combination can relieve nerve pain more effectively than a placebo. In one study, 24% of patients using the THC:CBD mix experienced significant relief, compared to just 8% who took a placebo. These findings suggest that both CBD alone and the THC:CBD combination may help reduce CIPN symptoms in cancer survivors. Arm III will serve as a placebo comparator. ^{1 2 6 7 8}

Who Is on the Research Team?

Richard Lee

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

Documented informed consent of the participant and/or legally authorized representative. Assent, when appropriate, will be obtained per institutional guidelines

Ability to read and understand English for questionnaires

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12137501/

Cannabidiol and multi-modal exercise for chemotherapy ... This study explored the effectiveness of cannabidiol (CBD) alone and in combination with multi-modal exercise (MME) to improve signs and symptoms of ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.12020

Safety and efficacy of cannabidiol in the management ... Thus, this preliminary study provides evidence that CBD, dosed at 135 mg/day, might serve as a treatment for some CIPN symptoms without serious ...

3. mdpi.com mdpi.com/1424-8247/17/7/834

Impact of Cannabidiol and Exercise on Clinical Outcomes ... Despite improvements in survivorship rates, chemotherapy-induced peripheral neuropathy (CIPN) remains a side effect in up to 80% of breast cancer survivors who ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923007055

Cannabinoids: an Effective Treatment for Chemotherapy ... In animal models, cannabinoids suppress neuropathic pain induced by traumatic nerve injury, toxic insults, and metabolic changes [32], although the role of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05672342

Study Details | NCT05672342 | Phytocannabinoids for the ... This clinical trial tests how well phytocannabinoids (cannabidiol [CBD] and tetrahydrocannbinol [THC]) work in reducing chronic chemotherapy-induced ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05388058

Study Details | NCT05388058 | Topical Cannabidiol for the ... This clinical trial compares topical cannabidiol to placebo in improving chemotherapy-induced peripheral neuropathy, or painful sensations in your hands or ...

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-08847

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.

8. mdpi.com mdpi.com/2227-9059/13/8/1921

Comparative Effects of THC and CBD on Chemotherapy ... Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cumulative dosage [1], with considerable variability in symptoms and severity [2].