PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy

NCT05246670 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: ACCRU-SC-2102NCI-2022-00002P30CA015083
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score

  Will be scored and summarized at each time point for each patient. The change from baseline to 8 weeks will then be calculated for each patient. The mean, standard deviation, and median (range) of the change will be calculated for each PEA arm and the combined placebo arm. The difference in change scores between each PEA arm and the combined placebo will be estimated along with a 95% confidence interval. For the primary analysis, the CIPN20 analysis dataset will include all eligible patients who are randomized, initiated treatment, and completed the baseline questionnaire. For patients who go off protocol treatment before 8 weeks, the score at their final observation will be used to calculate the change. The CIPN20 includes 20 items, each asking a participant to rate their experience with certain symptoms from 1 to 4, with 1 being no difficulty with the symptom and 4 being the most difficulty with the symptom. Answers are then summed to give a total score from 20 to 80.

  8 weeks

Secondary Outcomes (2)

• Number of Participants Experiencing Grade 3+ Adverse Events

  8 weeks

• Mean Change of Quality of Life

  8 weeks

Other Outcomes (8)

• Change in the Two Cognitive Items of the Cognitive Functioning Assessment

  Baseline up to 8 weeks

• Weekly CIPN20 Scores

  Baseline up to 8 weeks

• Weekly Pain Scores

  Baseline up to 8 weeks

Study Arms (4)

BID placebo

PLACEBO COMPARATOR

Patients receive placebo PO BID for 8 weeks.

Drug: Placebo Administration; Other: Quality-of-Life Assessment

Higher-dose PEA

EXPERIMENTAL

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

Drug: Palmidrol; Other: Quality-of-Life Assessment

Lower-dose PEA

EXPERIMENTAL

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

Drug: Palmidrol; Other: Quality-of-Life Assessment

QD placebo

PLACEBO COMPARATOR

Patients receive placebo PO QD for 8 weeks.

Drug: Placebo Administration; Other: Quality-of-Life Assessment

Interventions

Palmidrol DRUG

Given PEA PO

Also known as: N-Palmitoyl Ethanolamide, N-Palmitoylethanolamide, OptiPEA, Palmitoyl Ethanolamide, Palmitoylethanolamide, PEA

Higher-dose PEA; Lower-dose PEA

Placebo Administration DRUG

Given PO

BID placebo; QD placebo

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

BID placebo; Higher-dose PEA; Lower-dose PEA; QD placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Academic and Community Cancer Research United: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Middlesex Hospital

Middletown, Connecticut, 06457, United States

Location

Carle Cancer Center NCI Community Oncology Research Program

Urbana, Illinois, 61801, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cone Health Cancer Center

Greensboro, North Carolina, 27403, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Mayo Clinic Health System Eau Claire Hospital-Luther Campus

Eau Claire, Wisconsin, 54703, United States

Location

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

palmidrol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Mellar P. Davis, MD, FCCP, FAAHPM
• Organization: Geisinger Medical Center

mdavis2@geisinger.edu

570-271-7383

Study Officials

• Mellar P Davis

  Academic and Community Cancer Research United

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 18, 2022
• Study Start: May 16, 2022
• Primary Completion: February 12, 2024
• Study Completion: February 28, 2026
• Last Updated: September 22, 2025
• Results First Posted: January 24, 2025

Record last verified: 2025-09

Locations

US (10)