Back to resultsPhotobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy
Primary Purpose
Neuropathy, Neuropathy, Diabetic, Neuropathy Toxic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Realief Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathy focused on measuring chemotherapy, chemo-induced, CIPN
Eligibility Criteria
Inclusion Criteria: self reported neuropathy following exposure to diabetes or chemotherapy
- willingness to undergo biopsies and 6 weeks of therapy
Exclusion Criteria:
- pregnancy
- active cancer treatment
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Photobiomodulation
Arm Description
All patients will be treated similarly in this study
Outcomes
Primary Outcome Measures
change in epidermal nerve density and/or distribution
nerve measures include epidermal penetration points
total nerve fiber density,
nerve measures
Secondary Outcome Measures
Brief Pain index
NTSS- Nueropathy Total Symptom Score
This is a 15 question survey with yes or no answers. Averaged for scoring
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03195868
Brief Title
Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy
Official Title
A Comparative Analysis of Changes in Peripheral Nerve Density and Structure Following Photobiomodulation Therapy Using the REALief Therapy System for Patients With Diabetic or Chemotherapy-associated Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
January 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study seeks to determine if photobiomodulation (PBM, or low level laser light) affects the growth and distribution of nerves int he skin. Our previous study demonstrated that the treatment we use here was effective at reducing the symptoms of neuropathy (as measured by the modified total neuropathy score) in patients who had been treated with chemotherapy. The current effort is designed to repeat this confirm this observation using a more extensive battery of survey as well as to begin to elucidate the mechanism through which photobiomodulaiton produces the effect. WE will also be attempting to determine if diabetic patients differ in terms of response from chemotherapy patients
Detailed Description
Consenting patients with self-reported neuropathy following either diabetes or administration of chemotherapy, will undergo sensory testing and skin biopsies of the the foot and leg prior to initiating treatment. They will undergo PBM 3 times weekly for 6 weeks with with a follow-up biopsy performed at the conclusion of therapy and sensory testing throughout. Patients will have one remote evaluation at 26 weeks to determine whether the effect, if any extinguishes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy, Neuropathy, Diabetic, Neuropathy Toxic
Keywords
chemotherapy, chemo-induced, CIPN
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, prospective cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Photobiomodulation
Arm Type
Experimental
Arm Description
All patients will be treated similarly in this study
Intervention Type
Device
Intervention Name(s)
Realief Therapy
Other Intervention Name(s)
biopsies (skin, diagnostic not therapeutic)
Intervention Description
Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers
Primary Outcome Measure Information:
Title
change in epidermal nerve density and/or distribution
Description
nerve measures include epidermal penetration points
Time Frame
Change at Baseline 6 weeks, 26 weeks
Title
total nerve fiber density,
Description
nerve measures
Time Frame
Change at Baseline 6 weeks, 26 weeks
Secondary Outcome Measure Information:
Title
Brief Pain index
Time Frame
Change at Baseline 6 weeks, 26 weeks
Title
NTSS- Nueropathy Total Symptom Score
Description
This is a 15 question survey with yes or no answers. Averaged for scoring
Time Frame
Change at Baseline 6 weeks, 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: self reported neuropathy following exposure to diabetes or chemotherapy
willingness to undergo biopsies and 6 weeks of therapy
Exclusion Criteria:
pregnancy
active cancer treatment
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27887804
Citation
Argenta PA, Ballman KV, Geller MA, Carson LF, Ghebre R, Mullany SA, Teoh DG, Winterhoff BJ, Rivard CL, Erickson BK. The effect of photobiomodulation on chemotherapy-induced peripheral neuropathy: A randomized, sham-controlled clinical trial. Gynecol Oncol. 2017 Jan;144(1):159-166. doi: 10.1016/j.ygyno.2016.11.013. Epub 2016 Nov 22.
Results Reference
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Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy
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