88 Participants Needed

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

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

MP

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.
See 18 more

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.
See 7 more

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
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Lower-dose PEAExperimental Treatment2 Interventions
Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity.
Group II: Higher-dose PEAExperimental Treatment2 Interventions
Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.
Group III: QD placeboPlacebo Group2 Interventions
Patients receive placebo PO QD for 8 weeks.
Group IV: BID placeboPlacebo Group2 Interventions
Patients receive placebo PO BID for 8 weeks.

Find a Clinic Near You

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+
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