PEA for Chemotherapy-Induced Peripheral Neuropathy

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

88 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial tests whether PEA works to relieve the symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer. Chemotherapy-induced peripheral neuropathy refers to a nerve problem that causes pain, numbness, tingling, or muscle weakness in different parts of the body, and is caused by chemotherapy. PEA may be useful against bothersome nerve symptoms.

Research Team

Mellar P Davis

Principal Investigator

Academic and Community Cancer Research United

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+