Characterization and Treatment of Chemotherapy Neuropathy (CIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01557608
Recruitment Status : Unknown
Verified March 2016 by Christine Miaskowski, University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : March 19, 2012
Last Update Posted : March 31, 2016
Information provided by (Responsible Party):
Christine Miaskowski, University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
Chemotherapy-induced Neuropathy Procedure: Photon stimulation Procedure: Placebo treatment Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
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
Study Start Date : April 2012
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

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

  2. 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

  3. 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.

  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01557608

United States, California
University of California
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Christine A. Miaskowski, RN, PHD University of California, San Francisco
Principal Investigator: Bradley Aouizerat, PhD University of California, San Francisco

Responsible Party: Christine Miaskowski, Professor, University of California, San Francisco Identifier: NCT01557608     History of Changes
Other Study ID Numbers: R01CA151692 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by Christine Miaskowski, University of California, San Francisco:
photon stimulation

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases