drugset / Trial / NCT05246670

PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy

NCT05246670 ↗

RandomizedParallel-groupDouble-blindSupportive care

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.

Timeline

Start
2022-05-16
Primary completion
2024-02-12
Completion
2026-02-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Lower-dose PEA vs Combined Placebo; Mean Difference (Final Values) 2.21 (95% CI -1.33 to 5.74) NCT05246670 ↗

registry analysis (superiority test); Higher-dose PEA vs Combined Placebo; Mean Difference (Final Values) 0.09 (95% CI -5.23 to 5.41) NCT05246670 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Palmidrol Small molecule — Oral