Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281853
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2006-01-24
Brief Title:
Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Characterization of ChemotherapyBiotherapy-Induced Peripheral Neuropathy Refinement of Clinical Measures
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE This clinical trial is studying peripheral neuropathy in patients who are receiving chemotherapy or biological therapy for cancer
Detailed 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASE-120411 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CASE-13Z04 | OTHER | None | None |