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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Chemotherapy-induced Peripheral Neuropathy	Device: photobiomodulation; Other: Sham treatment; Other: Physiotherapy	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Supportive Care
Official Title:	Prospective, Randomized, Double Blind Study of Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy
Study Start Date :	January 2014
Actual Primary Completion Date :	July 2015
Estimated Study Completion Date :	December 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Realief Therapy; 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; The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser.
Sham Comparator: Sham Treatment; 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; 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

Outcome Measures

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Primary Outcome Measures :

1. Improvement of total neuropathy score [ Time Frame: 8 weeks ]
   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.

Secondary Outcome Measures :

1. Impact of 1 month treatment delay [ Time Frame: 1 month ]
   To determine the impact of 1 month treatment delay on QOL and baseline neuropathy scores in untreated patients
2. Time to improvement in initial neuropathy score [ Time Frame: 8 weeks ]
   Time to earliest sign of improvement will be calculated using Kaplan-Meier curves and compared between the experimental and control group using a log-rank test.
3. Time to maximum improvement in neuropathy score [ Time Frame: 8 weeks ]
   Time to earliest sign of maximum improvement will be calculated using Kaplan-Meier curves and compared between the experimental and control group using a log-rank test.
4. Effect of treatment after discontinuation of therapy [ Time Frame: 16 weeks ]
   To determine if treatment effect persists after discontinuation of therapy
5. Response to combination of physiotherapy and photobiomodulation [ Time Frame: 16 weeks ]
   To determine if the addition of physiotherapy to photobiomodulation improves overall response at 8 weeks post therapy.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

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Locations

United States, Minnesota
University of Minnesota Gynecologic Cancer Center
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Investigators

Principal Investigator:	Peter Argenta, MD	University of Minnesota - Clinical and Translational Science Institute

More Information

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Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT02000908 History of Changes
Other Study ID Numbers:	2013LS085; WCC# 63 ( Other Identifier: University of Minnesota Women's Cancer Center )
First Posted:	December 4, 2013
Last Update Posted:	September 14, 2016
Last Verified:	September 2016

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

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

Additional relevant MeSH terms:

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases