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


N/A
21 Years
85 Years
Not Enrolling
Both
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

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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 CenterCleveland, Ohio  44106-5065