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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Neurotoxicity

Treatments: Procedure: management of therapy complications

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00281853

CASE-120411

P30CA043703 (U.S. NIH Grant/Contract)

CASE-13Z04 (Other Identifier)

CASE13Z04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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