Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures
21 Years
85 Years
Both
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of cancer
- Scheduled to be treated with 1 of the following agents:
- Cisplatin/paclitaxel combination
- Biologic therapy with high-dose interferon alfa
PATIENT CHARACTERISTICS:
- Normal vision OR vision corrected with glasses or contact lenses
- No diseases or disorders reducing peripheral nerve function, including any of the
following:
- Diabetes mellitus
- HIV/AIDS
- Uremia
- Spinal injuries
- Alcoholism
- CNS problems
- No hearing impairment
PRIOR CONCURRENT THERAPY:
- No prior biologic therapy or neurotoxic chemotherapy
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment
Outcome Time Frame:
baseline, and then weeks 4, 8, and 12 during study treatment
Safety Issue:
No
Principal Investigator
Constance Visovsky, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE13Z04
NCT ID:
NCT00281853
Start Date:
March 2005
Completion Date:
August 2007
Related Keywords:
- Neurotoxicity
- Unspecified Adult Solid Tumor, Protocol Specific
- neurotoxicity
- unspecified adult solid tumor, protocol specific
- Peripheral Nervous System Diseases
- Neurotoxicity Syndromes
Name | Location |
|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
