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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: management of therapy complications|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurotoxicity, unspecified adult solid tumor, protocol specific