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

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ClinicalTrials.gov Identifier: NCT02000908
Recruitment Status : Completed
First Posted : December 4, 2013
Results First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE November 27, 2013
First Posted Date  ICMJE December 4, 2013
Results First Submitted Date  ICMJE February 14, 2017
Results First Posted Date  ICMJE February 11, 2019
Last Update Posted Date February 11, 2019
Study Start Date  ICMJE January 2014
Actual Primary Completion Date January 7, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
Change of Total Neuropathy Score [ Time Frame: Baseline 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. Scale scoring is 0-<20 0 being no pain <20 =severe
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2013)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2013)
  • 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
  • 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.
  • 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.
  • Effect of treatment after discontinuation of therapy [ Time Frame: 16 weeks ]
    To determine if treatment effect persists after discontinuation of therapy
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy
Official Title  ICMJE Prospective, Randomized, Double Blind Study of Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Chemotherapy-induced Peripheral Neuropathy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: photobiomodulation
  • 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.

    Interventions:
    • Device: photobiomodulation
    • Other: Sham treatment
    • Other: Physiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2013)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 6, 2017
Actual Primary Completion Date January 7, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02000908
Other Study ID Numbers  ICMJE 2013LS085
WCC# 63 ( Other Identifier: University of Minnesota Women's Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Minnesota
Original Responsible Party Masonic Cancer Center, University of Minnesota
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Argenta, MD University of Minnesota
PRS Account University of Minnesota
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP