Characterization and Treatment of Chemotherapy Neuropathy (CIN)
|Chemotherapy-induced Neuropathy||Procedure: Photon stimulation Procedure: Placebo treatment||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Characterization of and Treatment for Chemotherapy-Induced Neuropathy|
- Changes over time in light touch sensation [ Time Frame: Treatment days 1, 2, 4, 6, and 8 ]Light touch sensation will be measured using Semmes Weinstein monofilaments.
- Safety measures [ Time Frame: Before and after each treatment on days 1 through 8 ]Skin will be assessed for redness and swelling.
- Changes over time in pain qualities [ Time Frame: Treatment days 2, 4, 6, 8 ]Pain qualities will be assessed using the Pain Qualities Assessment Scale
- Changes over time in average pain intensity [ Time Frame: Treatment days 1 through 8 ]Average pain will be assessed using a 0 to 10 numeric rating scale.
- Changes over time in worst pain intensity [ Time Frame: Treatment days 1 through 8 ]Worst pain will be assessed using a 0 to 10 numeric rating scale.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
|Experimental: Photon stimulation||
Procedure: Photon stimulation
The LED diode wavelength chosen for this study is 870 nanometers. When activated, the photon stimulator is preset to deliver 1800 Joules in a 7 minute treatment period. Patients will receive a total of 8 treatments, to both feet simultaneously, within a 14 day period depending on their schedule.
|Placebo Comparator: Placebo treatment||
Procedure: Placebo treatment
For patients who receive the placebo treatment, the electronic control unit will be deactivated (i.e., no energy is delivered) even though the indicator lights will be illuminated when the power switch is turned to the "ON" position. Using this procedure, the research nurse who administers the treatments and collects the outcome data will be blinded to the patients' group assignment.
This protocol is designed in two parts. Part 1 will use an "extreme phenotype" approach to evaluate the phenotypic and genotypic characteristics of chemotherapy induced neuropathy(CIN)in a sample of oncology patients who have completed their chemotherapy and did(n=400)and did not (n=200) develop CIN. Patients with and without CIN will be matched, in a 2 to 1 ratio, on their cancer diagnosis and CTX agents administered (i.e., only a platinum compound, only a taxane, or both). Patients will be recruited in cohorts of 30 to 40 to insure that the matching criteria are met and the 2:1 ratio is achieved.
In a single study visit, to take place at the outpatient CTSI CRC (CCRC) at Mt. Zion,participants will be enrolled, complete a battery of sensorimotor tests and questionnaires, and provide a single blood specimen for genomic analysis.
Part 2 will be a pilot study of a randomized, double-blind, placebo-controlled clinical trial (RDBPCT) of photon stimulation in a sample of patients (n=142) with CIN who participated in Part 1. Participants will be randomized to receive the active treatment or the placebo in a series of 8 treatments, lasting 7 minutes each, across a 14-day period. Participants will be assessed at baseline and after the 2nd, 4th, 6th, and 8th treatments with sensory, motor, balance, pain intensity and pain quality measures, mood, and quality of life measures. Blood specimens will be drawn on treatment days 1, 4, 5, and 8 for gene expression.
10.1 * Study design: 10.2 Check
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557608
|United States, California|
|University of California|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Christine A. Miaskowski, RN, PHD||University of California, San Francisco|
|Principal Investigator:||Bradley Aouizerat, PhD||University of California, San Francisco|