Characterization and Treatment of Chemotherapy Neuropathy

Completed · Not applicable · Has a placebo group

Conditions studied: Chemotherapy-induced Neuropathy

In brief

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.

Key facts

Study ID

NCT01557608

Run by

University of California, San Francisco

People needed

754

Starts

2012-04-01

Expected to finish

2015-12-08

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of California — San Francisco, California, United States

Full record on ClinicalTrials.gov

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