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Characterization of and Treatment for Chemotherapy-Induced Neuropathy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chemotherapy-induced Neuropathy

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Trial Information

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
expression.

10.1 * Study design: 10.2 Check


Inclusion Criteria:



1. is an adult >18 years of age;

2. has received a platinum compound and/or a taxane;

3. has completed a course of CTX;

4. has changes in sensation and/or pain in their feet of >3 months duration following
the completion of CTX;

5. has a rating of >3 on a 0 to 10 numeric rating scale (NRS) on any one of the
following sensations from the Pain Qualities Assessment Scale (i.e., numb, tender,
shooting, sensitive, electrical, tingling radiating, throbbing, cramping, itchy,
unpleasant),91

6. if they have pain associated with the CIN, has an average pain intensity score in
their feet of >3 on a 0 to 10 NRS;

7. has a Karnofsky Performance Status (KPS) score of >50;

8. is able to read, write, and understand English; and

9. signs a written informed consent.

Exclusion Criteria:

1. If they have CIN in their hands, because we have no experience treating CIN in
patients' hands with photon stimulation and the photon stimulator is designed to
provide treatment only to the feet.

2. Women will be excluded if they intend to become or are pregnant or lactating. Men and
women will be required to take active measures to prevent pregnancy while on the
study.

3. If unwilling to provide the scheduled blood specimens they will be excluded.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Changes over time in light touch sensation

Outcome Description:

Light touch sensation will be measured using Semmes Weinstein monofilaments.

Outcome Time Frame:

Treatment days 1, 2, 4, 6, and 8

Safety Issue:

No

Principal Investigator

Christine A. Miaskowski, RN, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

R01CA151692

NCT ID:

NCT01557608

Start Date:

April 2012

Completion Date:

October 2016

Related Keywords:

  • Chemotherapy-induced Neuropathy
  • cancer
  • chemotherapy
  • photon stimulation
  • neuropathy
  • pain
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

Name

Location
University of California San Francisco, California  94108