Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer
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.
|Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific||Procedure: management of therapy complications|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures|
- 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 ]
|Study Start Date:||March 2005|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Procedure: management of therapy complications
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281853
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Constance Visovsky, PhD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|