Nerve Function in Older Diabetic Patients Who Are Undergoing Chemotherapy for Metastatic Solid Tumors

Not Applicable

Completed

• Conditions: Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00263861
• Lead Sponsor: Case Comprehensive Cancer Center

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.

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-12-07
• Study First Submitted QC: 2005-12-07
• Study First Posted: 2005-12-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-10
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cutaneous sensation as measured by Semmes-Weinstein monofilaments	baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Gait and balance as measured by Tinetti Performance Oriented Assessment of Gait and Balance Instrument	baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Vibration as measured by tuning fork	baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Lower extremity muscle strength as measured by Dynamometer	baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Blood pressure changes	baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Glycemic control as measured by Glycosylated Hemoglobin Assay	baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment

Trial Locations

Locations (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States