Spots Global Cancer Trial Database for Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy

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Trial Identification

Brief Title: Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy

Official Title: Prospective, Randomized, Double Blind Study of Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy

Study ID: NCT02000908

Conditions

Chemotherapy-induced Peripheral Neuropathy

Interventions

photobiomodulation

Sham treatment

Physiotherapy

Study Description

Brief Summary: This is a 2-armed, randomized, sham-controlled, double-blinded clinical trial of photobiomodulation therapy using the Realief Therapy system. The patients will be randomized in a 3:4 ratio to treatment or sham arms.

Detailed Description: The treatments will be administered by a Realief Neuropathy Center therapist. The target surface area and treatment durations will be dictated by the Realief Therapy protocol according to their proprietary algorithm, which includes assessment of geographic areas involved and the degree of neuropathy experienced. For the trial, each patient will be given 18 treatments of 30-minute duration, scheduled every three times weekly. The treatments will include laser exposure of any or all of 27 differentiated areas of the legs, feet, cervical spine region and lumbar spine region, for durations of 3 to 30 minutes, based on the symptom presentation at the time. Power densities will vary from 5 to 12 watts, based on the symptom presentations through the course of therapy.