PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy
NCT05246670 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2025-09-22
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
Interventions
- DRUG
-
Palmidrol
Given PEA PO
- DRUG
-
Placebo Administration
Given PO
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Academic and Community Cancer Research United
lead OTHER
Principal Investigators
-
Mellar P Davis · Academic and Community Cancer Research United
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-16
- Primary Completion
- 2024-02-12
- Completion
- 2026-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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