PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy

NCT ID: NCT05246670

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2026-02-28

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To look for evidence of the efficacy of PEA (N-palmitoylethanolamide) at two different doses relative to placebo responses, as a treatment for chemotherapy-induced neuropathy (CIPN).

SECONDARY OBJECTIVES:

I. To assess the safety of PEA at the two study doses. II. To evaluate changes in patient-reported quality of life from baseline to the end of 8 weeks.

EXPLORATORY OBJECTIVES:

I. To explore whether PEA appears to affect cognition in the study patients. II. To explore the weekly trajectory of CIPN from baseline to 8 weeks. III. To explore the weekly trajectory of pain using the single-item numerical rating scale from baseline to 8 weeks.

IV. To explore the weekly patient global impression of change in each treatment arm from baseline to 8 weeks.

V. To explore the weekly chemotherapy induced peripheral neuropathy in each treatment arm from baseline to 8 weeks.

VI. To explore the PEA effects on CIPN20 between two PEA dosage arms. VII. To explore the number of recurrent cancer events by study arm. VIII. To explore the overall survival by study arm.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients receive PEA orally (PO) once daily (QD) for 8 weeks as long as there is not any unacceptable toxicity.

ARM II: Patients receive PEA PO twice daily (BID) for 8 weeks as long as there is not any unacceptable toxicity.

ARM III: Patients receive placebo PO QD for 8 weeks.

ARM IV: Patients receive placebo PO BID for 8 weeks.

After completion of study intervention, patients are followed up at 6 and 12 months.

Conditions

Chemotherapy-Induced Peripheral Neuropathy; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

BID placebo

Patients receive placebo PO BID for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo Administration

Intervention Type: DRUG

Given PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Higher-dose PEA

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

Group Type: EXPERIMENTAL

Palmidrol

Intervention Type: DRUG

Given PEA PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Lower-dose PEA

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

Group Type: EXPERIMENTAL

Palmidrol

Intervention Type: DRUG

Given PEA PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

QD placebo

Patients receive placebo PO QD for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo Administration

Intervention Type: DRUG

Given PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Interventions

Palmidrol

Given PEA PO

Intervention Type: DRUG

Placebo Administration

Given PO

Intervention Type: DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

N-Palmitoyl Ethanolamide; N-Palmitoylethanolamide; OptiPEA; Palmitoyl Ethanolamide; Palmitoylethanolamide; PEA; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• 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
• Provide written informed consent =< 28 days prior to registration

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Academic and Community Cancer Research United

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mellar P Davis

Role: PRINCIPAL_INVESTIGATOR

Academic and Community Cancer Research United

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2022-00002

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACCRU-SC-2102

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ACCRU-SC-2102

Identifier Type: -

Identifier Source: org_study_id