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

Completed · Not applicable · Has a placebo group

Conditions studied: Chemotherapy-induced Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT02000908

Run by

University of Minnesota

People needed

70

Starts

2014-01-01

Expected to finish

2017-01-06

Last updated by the study team

2019-02-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• University of Minnesota Gynecologic Cancer Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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