PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID: NCT05246670
Run by: Academic and Community Cancer Research United
People needed: 88
Starts: 2022-05-16
Expected to finish: 2026-02-28
Last updated by the study team: 2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
NOTE: Patients with a history of metastatic cancer or an ECOG performance status of 2 must have laboratory (lab) work completed =< 28 days prior to registration
Pain, numbness, tingling or other symptoms of CIPN of >= 3 months (90 days) duration for which the patient is seeking an intervention
Neurotoxic chemotherapy must have been completed >= 3 months (90 days) prior to registration and there must be no further planned neurotoxic -chemotherapy for > 2 months after registration Note: The study is limited to those with taxane- and/or platinum-based neuropathy
Patient must note tingling, numbness or pain symptoms of at least a four out of ten =< 7 days prior to registration.
Note: On a 0-10 scale where zero was 'no problem' and ten being 'as bad a problem that could be imagined': how much of a problem has numbness, tingling, and/or pain in your fingers and/or toes been in the past week?
Patient must be able to speak, read and comprehend English
For women of childbearing potential only, a negative urine or serum pregnancy test done =< 14 days prior to registration is required
A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
NOTE: If the urine test cannot be confirmed as negative, a serum pregnancy test will be required
Life expectancy >= 6 months
Platelet count > 100,000/mm\^3
NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration
Absolute neutrophil count (ANC) >= 1,000/mm\^3
NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration
Hemoglobin > 11 g/dL
NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration
Serum transaminase (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) =< 1.2 x upper limit of normal (ULN)
NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have these labs completed =< 28 days prior to registration
Alkaline phosphatase =< 1.2 x ULN
NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration
Serum creatinine =< 1.2 x ULN
NOTE: Patients with a history of metastatic cancer or an ECOG performance status of 2 must have this lab completed =< 28 days prior to registration
Able to swallow oral medication

You may not qualify if…

Currently receiving neurotoxic chemotherapy for a second cancer or recurrence of the primary cancer
Impaired decision-making capacity (such as with a diagnosis of dementia or memory loss)
Evidence of residual cancer, per routine clinical practice-based parameters
Comorbid conditions:
Previous diagnosis of diabetic or another non chemotherapy induced peripheral neuropathy
Previous history of peripheral neuropathy prior to receiving neurotoxic chemotherapy
Neuropathy from human immunodeficiency virus (HIV) infection. Note: Patients with HIV infections are eligible as long as they do not have a neuropathy from their viral illness
Concurrent use of a cannabis product (tetrahydrocannabinol [THC] and/or cannabidiol [CBD]). Patients should have discontinued these products >= 4 weeks prior to registration
Current or previous use of PEA
Currently receiving or planning to start any of the following agents: opioids, duloxetine, gabapentin or pregabalin. Patients are eligible if they discontinue these medications >= 1 week prior to registration
Any of the following because the study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
Pregnant persons
Nursing persons
Persons of childbearing potential who are unwilling to employ adequate contraception

Where it is running

Middlesex Hospital — Middletown, Connecticut, United States
Carle Cancer Center NCI Community Oncology Research Program — Urbana, Illinois, United States
Siouxland Regional Cancer Center — Sioux City, Iowa, United States
Mayo Clinic — Rochester, Minnesota, United States
Cone Health Cancer Center — Greensboro, North Carolina, United States
Geisinger Medical Center — Danville, Pennsylvania, United States
Rapid City Regional Hospital — Rapid City, South Dakota, United States
Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
Mayo Clinic Health System Eau Claire Hospital-Luther Campus — Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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