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

Completed

• Conditions: Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00281853
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2006-01-24
• Study First Submitted QC: 2006-01-24
• Study First Posted: 2006-01-25
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-10
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment	baseline, and then weeks 4, 8, and 12 during study treatment
Vibratory sensation as measured by tuning fork at baseline, and then weeks 4, 8, and 12 during study treatment	baseline, and then weeks 4, 8, and 12 during study treatment
Blood pressure changes at baseline, and then weeks 4, 8, and 12 during study treatment	baseline, and then weeks 4, 8, and 12 during study treatment

Trial Locations

Locations (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States