Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-25 @ 5:39 PM
Study NCT ID:
NCT02000908
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2013-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Prospective, Randomized, Double Blind Study of Photobiomodulation Therapy Using the Realief Therapy System for the Treatment of Chemotherapy-associated Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| WCC# 63 | OTHER | University of Minnesota Women's Cancer Center | View |