Laser Photobiomodulation Therapy to Treat Neuropathic Pain Caused by Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients A Randomized, Placebo-Controlled Phase II Clinical Trial

What this Trial Is About

Chemotherapy-induced peripheral neuropathy CIPN is a common side effect experienced by cancer patients after chemotherapy, causing symptoms such as numbness, pain, and sensory changes typically in the hands and feet. Neuropathic pain is a major feature of CIPN and can significantly reduce quality of life by contributing to psychological distress, risk of falls, cognitive difficulties, and sleep problems. There are currently no proven preventive treatments for CIPN, and drug options for neuropathic pain relief remain limited. This trial aims to evaluate the effectiveness, feasibility, and safety of laser photobiomodulation PBM as a treatment for neuropathic pain in CIPN patients. Participants will receive photobiomodulation therapy using an ATP38 device that delivers laser light at specific wavelengths to the hands andor feet. The treatment consists of two sessions per week for four weeks, totaling eight sessions. Each session lasts 13 minutes, with laser light applied in a counterbalanced order between feet and hands. Certified clinicians will administer the therapy while patients are seated and wear protective glasses. A control group will receive sham therapy mimicking the procedure without active laser light, with an option to receive real treatment after the study. During the study, participants will be assessed for neuropathic pain and other related symptoms at baseline, throughout treatment, and up to 12 weeks after treatment completion, with additional follow-up up to 6 months. Evaluations include pain intensity, quality of life, sleep disorders, neurocognitive function, and emotional distress. Researchers will also monitor treatment adherence and safety. The total duration of participation spans from the start of treatment through extended follow-up visits to track pain evolution and potential benefits of photobiomodulation therapy.

Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy in Cancer Patients