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

Case Comprehensive Cancer Center15 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific

Interventions

management of therapy complicationsPROCEDURE

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment

Time frame: 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

Time frame: 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

Time frame: baseline, and then weeks 4, 8, and 12 during study treatment

Data from ClinicalTrials.gov

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