Back to results

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

Primary Purpose

Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

management of therapy complications

About this trial

This is an interventional supportive care trial for Neurotoxicity focused on measuring neurotoxicity, unspecified adult solid tumor, protocol specific

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of solid tumor Metastatic disease (stage IV) Planning neoadjuvant or adjuvant treatment of locoregional definitive or systemic therapy comprising ≥ 1 of the following: Taxane (paclitaxel or docetaxel) Platinum (cisplatin, carboplatin, or oxaliplatin) Diagnosis of type I or II diabetes mellitus PATIENT CHARACTERISTICS: Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No other disease that reduces peripheral nerve function (e.g., HIV/AIDS, uremia, spinal injuries, alcoholism, or CNS problems) PRIOR CONCURRENT THERAPY: Chemotherapy See Disease Characteristics No prior chemotherapy No prior or concurrent neurotoxic drugs (i.e., vincristine)

Sites / Locations

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Cutaneous sensation as measured by Semmes-Weinstein monofilaments

Gait and balance as measured by Tinetti Performance Oriented Assessment of Gait and Balance Instrument

Vibration as measured by tuning fork

Lower extremity muscle strength as measured by Dynamometer

Blood pressure changes

Glycemic control as measured by Glycosylated Hemoglobin Assay

Secondary Outcome Measures

Full Information

NCT ID

NCT00263861

First Posted

December 7, 2005

Last Updated

June 10, 2010

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00263861

Brief Title

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

Official Title

Impact of Treatment With Taxane or Platinum-Containing Regimens on Peripheral Nerve Functioning in Older Cancer Patients With Diabetes: An Exploratory Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

neurotoxicity, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

management of therapy complications

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cutaneous sensation as measured by Semmes-Weinstein monofilaments

Time Frame