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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary:

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 Summary:

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.


Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: January 24, 2006
Date Started: March 2005
Date Completion:
Last Updated: June 10, 2010
Last Verified: June 2010