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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurotoxicity, unspecified adult solid tumor, protocol specific