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

NCT02000908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-02-11

Study results available
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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.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DEVICE

photobiomodulation

The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser.

OTHER

Sham treatment

All patients in sham treatment arm cross over to laser therapy followed by physiotherapy

OTHER

Physiotherapy

Chiropractic massage and lymphedema treatment

Sponsors & Collaborators

Principal Investigators

  • Peter Argenta, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-07
Completion
2017-01-06

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000908 on ClinicalTrials.gov