Characterization and Treatment of Chemotherapy Neuropathy

NCT01557608 | Completed DMC

• 1 other identifier: R01CA151692
• Study Type: interventional
• Target: 754
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Neuropathy

Keywords

cancer; chemotherapy; photon stimulation; neuropathy; pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Safety measures

  Before and after each treatment on days 1 through 8

• Changes over time in pain qualities

  Treatment days 2, 4, 6, 8

• Changes over time in average pain intensity

  Treatment days 1 through 8

• Changes over time in worst pain intensity

  Treatment days 1 through 8

Study Arms (2)

Photon stimulation

EXPERIMENTAL

Procedure: Photon stimulation

Placebo treatment

PLACEBO COMPARATOR

Procedure: Placebo treatment

Interventions

Photon stimulation PROCEDURE

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.

Photon stimulation

Placebo treatment PROCEDURE

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.

Placebo treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is an adult \>18 years of age;
• has received a platinum compound and/or a taxane;
• has completed a course of CTX;
• has changes in sensation and/or pain in their feet of \>3 months duration following the completion of CTX;
• 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
• 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;
• has a Karnofsky Performance Status (KPS) score of \>50;
• is able to read, write, and understand English; and
• signs a written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christine A. Miaskowski, RN, PHD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Bradley Aouizerat, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 19, 2012
• Study Start: April 1, 2012
• Primary Completion: December 8, 2015
• Study Completion: December 8, 2015
• Last Updated: January 14, 2020

Record last verified: 2020-01

Locations

US (1)