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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263861
• Other study ID #: CWRU6Z03
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: N/A
• First received: December 7, 2005
• Last updated: June 10, 2010
• Start date: March 2005
• Est. completion date: September 2007

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neurotoxicity
• Neurotoxicity Syndromes
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

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.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutaneous sensation as measured by Semmes-Weinstein monofilaments		baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment	No
Primary	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	No
Primary	Vibration as measured by tuning fork		baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment	No
Primary	Lower extremity muscle strength as measured by Dynamometer		baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment	No
Primary	Blood pressure changes		baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment	No
Primary	Glycemic control as measured by Glycosylated Hemoglobin Assay		baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment	No