PEA for Chemotherapy-Induced Peripheral Neuropathy

Not currently recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Academic and Community Cancer Research United

Must not be taking: Opioids, Duloxetine, Gabapentin, Pregabalin

Disqualifiers: Dementia, Residual cancer, Diabetic neuropathy, others

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether PEA, a potential treatment, can ease symptoms of chemotherapy-induced peripheral neuropathy, which causes pain, numbness, or tingling due to nerve damage from cancer treatment. Researchers are testing two doses of PEA to determine its effectiveness compared to a placebo, which contains no active drug. The trial suits cancer patients who continue to experience these nerve issues at least three months after completing neurotoxic chemotherapy and seek relief from these symptoms. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking certain medications like cannabis products, opioids, duloxetine, gabapentin, or pregabalin before joining the trial. Specifically, cannabis products should be stopped at least 4 weeks before, and opioids, duloxetine, gabapentin, or pregabalin should be stopped at least 1 week before registration.

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

Research has shown that PEA is usually well-tolerated. A previous study found no major differences in side effects between different doses of PEA, suggesting it doesn't cause significant side effects.

As this trial is in an early stage, researchers continue to assess the safety of PEA for larger groups. However, the results so far are promising, with no serious safety concerns reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chemotherapy-induced peripheral neuropathy?

Researchers are excited about PEA for chemotherapy-induced peripheral neuropathy because it's a naturally occurring compound that targets inflammation and nerve damage differently from typical treatments like antidepressants or anticonvulsants. Unlike these standard options, which primarily focus on symptom relief, PEA has anti-inflammatory properties and works by modulating the body's endocannabinoid system, potentially addressing the root cause of neuropathy. Additionally, PEA is administered orally, offering a non-invasive and straightforward delivery method, which is a significant advantage over treatments that require injections or other more complex administration.

What evidence suggests that PEA might be an effective treatment for chemotherapy-induced peripheral neuropathy?

Research has shown that Palmitoylethanolamide (PEA) might improve nerve function in individuals with chemotherapy-induced peripheral neuropathy (CIPN), a condition causing pain and numbness. Studies have found that PEA can enhance the function of nerve fibers crucial for proper nerve signaling. In some cases, PEA has even repaired nerve damage caused by chemotherapy. Additionally, early research suggests that PEA might not only treat CIPN but also prevent its onset. This trial will evaluate different dosages of PEA, with participants receiving either a lower or higher dose, or a placebo. These findings suggest that PEA could be a promising option for relieving symptoms related to nerve problems due to chemotherapy. ^{1 2 6 7 8}

Who Is on the Research Team?

Mellar P Davis

Principal Investigator

Academic and Community Cancer Research United

Are You a Good Fit for This Trial?

Adults with pain, numbness, or tingling from chemotherapy-induced peripheral neuropathy for at least 3 months can join this trial. They must have finished neurotoxic chemo at least 3 months ago and not plan to start any within the next 2 months. Participants need a stable blood count, be able to swallow pills, and women of childbearing age must test negative for pregnancy.

Inclusion Criteria

I had recent lab work if I have metastatic breast cancer or am somewhat limited in physical activities.

The levels of certain liver enzymes in your blood are not higher than normal.

I have felt tingling, numbness, or pain at a level of 4 out of 10 or more in the last week.

Exclusion Criteria

Pregnant persons, nursing persons, persons of childbearing potential who are unwilling to employ adequate contraception

I stopped using cannabis products at least 4 weeks ago.

I have nerve damage not caused by chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PEA or placebo orally for 8 weeks to assess efficacy and safety

8 weeks

Weekly assessments (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• PEA

Trial Overview The trial is testing PEA's effectiveness in relieving nerve pain symptoms caused by chemotherapy. Patients will either receive PEA or a placebo (a substance with no active drug) while their quality of life is monitored to see if there's an improvement in their symptoms.

How Is the Trial Designed?

Group I: Lower-dose PEA Experimental Treatment 2 Interventions

Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity.

Group II: Higher-dose PEA Experimental Treatment 2 Interventions

Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.

Group III: QD placebo Placebo Group 2 Interventions

Patients receive placebo PO QD for 8 weeks.

Group IV: BID placebo Placebo Group 2 Interventions

Patients receive placebo PO BID for 8 weeks.

Who Is Running the Clinical Trial?

Academic and Community Cancer Research United

Lead Sponsor

Trials

54

Recruited

4,900+

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/PMC11674762/

Treatment of Established Chemotherapy-Induced Neuropathy ... Palmitoylethanolamide (PEA) has been reported to improve myelinated nerve fiber function in patients experiencing painful CIPN. We conducted a ...

2. clinicaltrial.be clinicaltrial.be/en/details/32523?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

PEA for the Relief of Chemotherapy-Induced Peripheral ... Primary outcomes 1. Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score. Will be ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39766143/

A Randomized, Double-Blind Phase II Pilot Study Palmitoylethanolamide (PEA) has been reported to improve myelinated nerve fiber function in patients experiencing painful CIPN.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022356524194360

Palmitoylethanolamide Reverses Paclitaxel-Induced ... These findings taken together suggest that PEA possesses potential to treat peripheral neuropathy in cancer patients undergoing chemotherapy.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/26323524241266603

Novel drug treatments for pain in advanced cancer and ... There is significant preclinical evidence that PEA may effectively treat CIPN and prevent its occurrence. One non-placebo controlled trial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3500919/

Therapeutic utility of palmitoylethanolamide in the treatment of ... A multicenter double-blind study evaluating the efficacy and safety of PEA in chemotherapy-induced neuropathic pain is currently in progress.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0304383524008280

An emerging aspect of cancer neuroscience: A literature ... Chemotherapy-induced peripheral neuropathy (CIPN) is the most common side effects that significantly reduce the efficacy of anti-cancer treatment and patients' ...

8. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/chemotherapy-induced-peripheral-neuropathy

Chemotherapy-Induced Peripheral Neuropathy Clinical Trials The purpose of this study is to test the safety, side effects, and best dose of monosialotetrahexosylganglioside (GM1) and whether it works in reducing or ...