Characterization and Treatment of Chemotherapy Neuropathy (CIN)

This study is currently recruiting participants. (see Contacts and Locations)
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

February 28, 2012
May 25, 2013
April 2012
October 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01557608 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Characterization and Treatment of Chemotherapy Neuropathy
Characterization of and Treatment for Chemotherapy-Induced Neuropathy

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Chemotherapy-induced Neuropathy
  • 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.
  • 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.
  • Experimental: Photon stimulation
    Intervention: Procedure: Photon stimulation
  • Placebo Comparator: Placebo treatment
    Intervention: Procedure: Placebo treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
142
October 2016
October 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
United States
 
NCT01557608
R01CA151692
Yes
Christine Miaskowski, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Christine A. Miaskowski, RN, PHD University of California, San Francisco
Principal Investigator: Bradley Aouizerat, PhD University of California, San Francisco
University of California, San Francisco
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP