Molecular-Genetic Mechanisms Associated With Chemotherapy-Induced Nerve Damage

NCT01293851 | Terminated

• 2 other identifiers: 11006511-NR-0065
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Peripheral Neuropathic Pain; Neurotoxicity; Cancer

Keywords

Biomarkers; Gene Expression; Neuropathic Pain; Neurotoxicity; Chemotherapy; Peripheral Neuropathic Pain; Cancer

Eligibility Criteria

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

You may qualify if:

• Patients must meet all of the following to be eligible for enrollment:
• Age: 18 years and older
• Both male and female cancer patients will be recruited in this study. However, data will be separately assessed between males and females due to the differences in incidence, etiology and hormonal dependence which may confound the final data analyses.
• Ability to provide informed consent
• Cancer patients scheduled to undergo chemotherapy with taxane class, vinca alkaloid class, platinum compounds or bortezomib

You may not qualify if:

• Patients with any one of the following will be excluded:
• Unable to provide their own informed consent
• Have had prior radiotherapy
• Pre-existing documented neuropathy or risk factors for neuropathy that may confound the analysis of factors associated with CIPN such as:
• Diabetes mellitus
• Uremia
• Vitamin B12 deficiency
• Peripheral vascular disease
• Documented Thyroid dysfunction with on-going treatment. The patients who have thyroid dysfunction may also manifest the peripheral neuropathic symptoms such as numbness and tingling on their feet and hands. The medications used to treat hypothyroidism may confound the study data assessment.
• Previous history of alcoholism (beriberi) or drug abuse
• Rheumatoid arthritis
• Lupus
• Amyloidosis
• Sarcoidosis
• Other drug-induced neuropathy that may confound the analysis associated with CIPN such as:

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Hoyert DL, Heron MP, Murphy SL, Kung HC. Deaths: final data for 2003. Natl Vital Stat Rep. 2006 Apr 19;54(13):1-120.

  PMID: 16689256 BACKGROUND

• Thase ME, Frank E, Mallinger AG, Hamer T, Kupfer DJ. Treatment of imipramine-resistant recurrent depression, III: Efficacy of monoamine oxidase inhibitors. J Clin Psychiatry. 1992 Jan;53(1):5-11.

  PMID: 1737741 BACKGROUND

• Cmelak AJ, Murphy BA, Burkey B, Douglas S, Shyr Y, Netterville J. Taxane-based chemoirradiation for organ preservation with locally advanced head and neck cancer: results of a phase II multi-institutional trial. Head Neck. 2007 Apr;29(4):315-24. doi: 10.1002/hed.20522.

  PMID: 17252600 BACKGROUND

MeSH Terms

Conditions

Neurotoxicity Syndromes; Neoplasms; Neuralgia

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiao Min Wang, M.D.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: February 11, 2011
• Study Start: December 22, 2010
• Study Completion: November 13, 2012
• Last Updated: December 5, 2019

Record last verified: 2012-11-13

Locations

US (1)