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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Neurotoxicity

Treatments: Procedure: management of therapy complications

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00263861

P30CA043703 (U.S. NIH Grant/Contract)

CWRU6Z03

CASE-CWRU-6Z03 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)