Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer
|ClinicalTrials.gov Identifier: NCT00281853|
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : June 11, 2010
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.
|Condition or disease||Intervention/treatment|
|Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific||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.
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|Official Title:||Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures|
|Study Start Date :||March 2005|
|Primary Completion Date :||August 2007|
|Study Completion Date :||August 2007|
Procedure: management of therapy complications
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|