Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263861
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2005-12-07
Brief Title:
Nerve Function in Older Diabetic Patients Who Are Undergoing Chemotherapy for Metastatic Solid Tumors
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Impact of Treatment With Taxane or Platinum-Containing Regimens on Peripheral Nerve Functioning in Older Cancer Patients With Diabetes An Exploratory Study
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 side effects of chemotherapy may help plan treatment and may help patients live more comfortably
PURPOSE This clinical trial is studying nerve function in older diabetic patients who are undergoing chemotherapy for metastatic solid tumors
PURPOSE This clinical trial is studying nerve function in older diabetic patients who are undergoing chemotherapy for metastatic solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine changes in peripheral nerve function in older patients with diabetes and metastatic solid tumors treated with taxane or platinum-containing chemotherapy regimens
Determine the extent to which age pre-existing diabetes mellitus and level of glycemic control predict a differential pattern in outcome beyond the effect of the drugs in patients treated with these regimens
Develop a clinical assessment that would predict whether or not patients with diabetes mellitus are more or less susceptible to the neurotoxic effects of chemotherapy
OUTLINE This is a longitudinal study
Patients undergo an interview and clinical evaluation to measure demographic data cutaneous sensation gait and balance vibration lower extremity muscle strength orthostatic blood pressure and glycemic control Patients are evaluated at baseline every 3 weeks during chemotherapy for up to 4 treatments and at 2 months after completion of treatment
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine changes in peripheral nerve function in older patients with diabetes and metastatic solid tumors treated with taxane or platinum-containing chemotherapy regimens
Determine the extent to which age pre-existing diabetes mellitus and level of glycemic control predict a differential pattern in outcome beyond the effect of the drugs in patients treated with these regimens
Develop a clinical assessment that would predict whether or not patients with diabetes mellitus are more or less susceptible to the neurotoxic effects of chemotherapy
OUTLINE This is a longitudinal study
Patients undergo an interview and clinical evaluation to measure demographic data cutaneous sensation gait and balance vibration lower extremity muscle strength orthostatic blood pressure and glycemic control Patients are evaluated at baseline every 3 weeks during chemotherapy for up to 4 treatments and at 2 months after completion of treatment
PROJECTED ACCRUAL A total of 50 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-CWRU-6Z03 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |