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 symptoms and quality of life from baseline to the end of 8 weeks.~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.
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.