Characterization of and Treatment for Chemotherapy-Induced Neuropathy
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
10.1 * Study design: 10.2 Check
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Changes over time in light touch sensation
Light touch sensation will be measured using Semmes Weinstein monofilaments.
Treatment days 1, 2, 4, 6, and 8
Christine A. Miaskowski, RN, PHD
University of California, San Francisco
United States: Institutional Review Board
|University of California||San Francisco, California 94108|