NCT00281853

Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer

Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve function may help doctors plan treatment and help patients live more comfortably. PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving chemotherapy or biological therapy for cancer.

Detailed description

OBJECTIVES: * Determine the change in peripheral nerve function in cancer patients during and after treatment with chemotherapy or biologic therapy. * Determine the clinical measurement of hearing-related air and bone conduction and vibratory sensation in these patients. * Correlate the changes in orthostatic blood pressure using both the Vasotrac automated blood pressure device and the standard clinical automated blood pressure equipment. * Determine the patient's perception of hearing quality before and after treatment with chemotherapy or biologic therapy. OUTLINE: This is a multicenter study. Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Conditions

• Neurotoxicity
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
PROCEDURE	management of therapy complications	Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2006-01-25
• Last updated: 2010-06-11

Locations

1 site across 1 country: United States