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NCT01293851 · ClinicalTrials.gov registry record
Molecular-Genetic Mechanisms Associated With Chemotherapy-Induced Nerve Damage
A clinical trial, sponsored by National Institute of Nursing Research (NINR).
- Terminated
- Registry status
- 3
- Enrollment target
NCT01293851 is a clinical trial that was terminated before completion, run by National Institute of Nursing Research (NINR). The registered enrollment target is 3 participants.
The verdict
NCT01293851 was terminated before completion, sponsored by National Institute of Nursing Research (NINR).
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2010-12-22 |
| Est. Completion | 2012-11-13 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01293851
The ClinicalTrials.gov registry entry for NCT01293851 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Nursing Research (NINR), which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01293851 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01293851 about?
NCT01293851 is a clinical study titled "Molecular-Genetic Mechanisms Associated With Chemotherapy-Induced Nerve Damage". 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...
What is the current status of trial NCT01293851?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2010-12-22. Estimated completion is 2012-11-13.
Who is sponsoring clinical trial NCT01293851?
This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.
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