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

NCT02000908 | Completed Results DMC

• 2 other identifiers: 2013LS085WCC# 63
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

gynecological cancer; ovarian cancer; primary peritoneal cancer; cervical caner; peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Change of Total Neuropathy Score

  For each patient, we will compute the difference between the total neuropathy score at 8 weeks (the end of treatment) and the total neuropathy score at the time of randomization. The mean change in score for the experimental group patients will be compared to the mean change in score for the control group patients using a two-sample t-test. Scale scoring is 0-\<20 0 being no pain \<20 =severe

  Baseline 8 weeks

Study Arms (2)

Realief Therapy

EXPERIMENTAL

Each patient will be given 15-18 treatments depending on response of 30-minute duration of photobiomodulation with the Realief Therapy system, scheduled every three times weekly for 5-6 weeks. 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.

Device: photobiomodulation

Sham Treatment

SHAM COMPARATOR

The placebo group will receive sham treatment, during which a heat probe will be guided over both lower extremities over a period of 30 minutes, consistent with the treatment arm. The laser device will be activated during the treatment so that the visual and auditory environment prior to therapy will be the same for both treatment and sham control. After 8 weeks of sham treatment the subjects in this arm will be offered the photobiomodulation combined with physiotherapy.

Device: photobiomodulation; Other: Sham treatment; Other: Physiotherapy

Interventions

photobiomodulation DEVICE

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

Realief Therapy; Sham Treatment

Sham treatment OTHER

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

Sham Treatment

Physiotherapy OTHER

Chiropractic massage and lymphedema treatment

Sham Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will have stable or worsening neuropathy (≥grade 2 CTCAE) after the completion of chemotherapy, with a presumptive remission. Patients who are interested in enrollment will have a baseline neuropathy assessment followed by a second evaluation 1 month later to confirm that the neuropathy is not spontaneously improving (greater than 10% improvement in their mTNS).
• Patients will be 18 years or older at the time of signing the consent.
• Patients must have GOG performance status of 0, 1, 2, or 3 (see appendix III), and be able to communicate both their symptoms and report the response to neurologic testing.
• Patients must have recovered from the acute and remediable effects of surgery, radiation therapy and/or chemoradiotherapy. At least 3 weeks must have elapsed from the last administration of chemotherapy, and at least three weeks must have elapsed from the last administration of a complete radiation therapy regimen alone or chemoradiation therapy.
• Patients with pre-existing neuropathy will be eligible, provided that they have not previously undergone laser therapy for the treatment of their condition.
• Patients must be sterile or on adequate birth control.
• Patients must have willingly signed an approved consent form, be willing to be randomized to intervention or sham therapy, and be willing to be blinded from directly observing therapy. Patients completing sham therapy will be offered Realief Therapy in conjunction with physiotherapy free of charge.
• Patients must be able to attend therapy at the Realief Neuropathy Center in St. Louis Park as dictated by the requirements of the protocol (3 times/week for up to 8 weeks as well as once 8 weeks following the completion of therapy) AND be evaluated at the University of Minnesota's Gynecologic Cancer Clinic for study assessments (4 planned assessments during and after therapy). Every effort will be made to co-ordinate these visits with routine health maintenance.
• Life expectancy \>6 months

You may not qualify if:

• Patients who have previously received a laser-based therapy for the treatment of neuropathy will be considered ineligible.
• Patients with a \> 10% improvement from the initial mTNS assessment to the mTNS assessment at the time of study enrollment (four weeks from the original assessment).
• Patients with evidence of direct tumor involvement of the nervous system (central or peripheral) will be considered ineligible.
• Patients who are pregnant will be considered ineligible. Class 4 lasers have been inadequately studied in this setting to conclude that there is no risk to a developing fetus.
• Patients with the inability to tolerate therapy or blinding due to co-morbid medical or psychiatric illness.
• Patients in active treatment of cancer will not be considered eligible.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Gynecologic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Peripheral Nervous System Diseases

Interventions

Low-Level Light Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Rehabilitation

Results Point of Contact

• Title: Peter Argenta MD
• Organization: University of Minnesota

argenta@umn.edu

612-626-3111

Study Officials

• Peter Argenta, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 4, 2013
• Study Start: January 1, 2014
• Primary Completion: January 7, 2016
• Study Completion: January 6, 2017
• Last Updated: February 11, 2019
• Results First Posted: February 11, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)