Characterization and Treatment of Chemotherapy Neuropathy (CIN)

This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Christine Miaskowski, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01557608
First received: February 28, 2012
Last updated: May 25, 2013
Last verified: May 2013
  Purpose

Numbness, tingling, and pain in the hands and feet following the administration of chemotherapy (also called chemotherapy-induced neuropathy (CIN)) is a common problem in oncology patients. However, more information is needed on why patients develop neuropathy and how it impacts their mood, ability to function, and their quality of life. In addition, effective treatments for this problem are not available at the present time. This study will be conducted in two parts. In Part 1, patients who have finished chemotherapy and did or did not develop CIN will be evaluated to determine why some patients do and other patients do not develop CIN. In addition, the impact of CIN on patients' mood, function, and quality of life will be evaluated by comparing patients' reports on these important outcome measures. In addition, genetic markers that contribute to or protect against the development of CIN will be evaluated. Part 2 of this study will test the effects of a new treatment called photon stimulation (also called infrared light therapy) compared to placebo treatment to improve sensations in the feet of oncology patients with CIN. Patients who receive the photon stimulation will have greater improvement in sensation in their feet compared with those who do not receive photon stimulation.


Condition Intervention Phase
Chemotherapy-induced Neuropathy
Procedure: Photon stimulation
Procedure: Placebo treatment
Phase 2

Study Type: 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
Official Title: Characterization of and Treatment for Chemotherapy-Induced Neuropathy

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Changes over time in light touch sensation [ Time Frame: Treatment days 1, 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
    Light touch sensation will be measured using Semmes Weinstein monofilaments.


Secondary Outcome Measures:
  • Safety measures [ Time Frame: Before and after each treatment on days 1 through 8 ] [ Designated as safety issue: Yes ]
    Skin will be assessed for redness and swelling.

  • Changes over time in pain qualities [ Time Frame: Treatment days 2, 4, 6, 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Worst pain will be assessed using a 0 to 10 numeric rating scale.


Estimated Enrollment: 142
Study Start Date: April 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557608

Contacts
Contact: Christine A Miaskowski, RN, PhD 415-476-9407 chris.miaskowski@nursing.ucsf.edu
Contact: Claudia West, RN, MS 415-476-5131 claudia.west@nursing.ucsf.edu

Locations
United States, California
University of California Recruiting
San Francisco, California, United States, 94143
Contact: Claudia West, RN, MS    415-476-5131    claudia.west@nursing.ucsf.edu   
Principal Investigator: Christine Miaskowski, RN, PhD         
Principal Investigator: Bradley Aouizerat, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Christine A. Miaskowski, RN, PHD University of California, San Francisco
Principal Investigator: Bradley Aouizerat, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Christine Miaskowski, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01557608     History of Changes
Other Study ID Numbers: R01CA151692
Study First Received: February 28, 2012
Last Updated: May 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
cancer
chemotherapy
photon stimulation
neuropathy
pain

Additional relevant MeSH terms:
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 15, 2014