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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-08-31

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.

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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.

Conditions

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Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No