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Molecular-Genetic Mechanisms Associated With Chemotherapy-Induced Nerve Damage

NCT01293851 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2019-12-05

No results posted yet for this study

Summary

Background:

\- Docetaxel, the most commonly used drug for the treatment of invasive breast cancer, has been shown to prolong the lives of women with breast cancer and prevent the cancer from spreading or returning. However, docetaxel is known to cause nerve damage, including numbness, tingling, and pain, in 50 to 90 percent of breast cancer patients. This nerve damage is called peripheral neuropathy, and can be so severe that treatment with docetaxel may need to be stopped. Researchers are interested in studying docetaxel-related nerve damage to determine whether certain genetic factors may predispose women to developing this condition, and to more closely investigate the specific effects of docetaxel on the nervous system

Objectives:

\- To examine nerve damage in women with breast cancer who are being treated with docetaxel.

Eligibility:

\- Women at least 18 years of age who have been diagnosed with invasive breast cancer and are scheduled to have docetaxel treatment.

Design:

* Participants will be screened with a full medical history and physical examination, as well as blood and urine tests and imaging studies.
* This study requires seven visits, one before the start of chemotherapy and six after the scheduled treatment visits. Study procedures at each visit will take 30 to 45 minutes and will be done in parallel with scheduled chemotherapy visits.
* At the first visit, participants will provide blood samples; complete questionnaires to rate and describe any existing pain, numbness, or tingling in hands and feet before the start of chemotherapy; have nerve conduction tests; and have a skin biopsy.
* At each visit following docetaxel treatment, participants will complete questionnaires to rate and describe any pain, numbness, or tingling during the course of chemotherapy. Participants will provide blood samples at every visit and have nerve conduction tests during the second, fourth, and sixth visits. Participants will also have a second skin biopsy, either from a site that appears to be experiencing nerve damage or (for those who are not developing nerve damage symptoms) from a site near the first biopsy location.

Conditions

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    lead NIH

Principal Investigators

  • Xiao Min Wang, M.D. · National Institute of Nursing Research (NINR)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-22
Completion
2012-11-13

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01293851 on ClinicalTrials.gov