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Nerve Function in Older Diabetic Patients Who Are Undergoing Chemotherapy for Metastatic Solid Tumors
This study has been completed.
First Received: December 7, 2005   Last Updated: May 9, 2009   History of Changes
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00263861
  Purpose

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.


Condition Intervention
Neurotoxicity
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: management of therapy complications

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Cutaneous sensation as measured by Semmes-Weinstein monofilaments at 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 at baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
  • Vibration as measured by tuning fork at baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
  • Lower extremity muscle strength as measured by Dynamometer at baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
  • Blood pressure changes at baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
  • Glycemic control as measured by Glycosylated Hemoglobin Assay at baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment

Estimated Enrollment: 50
Study Start Date: March 2005
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263861

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5047
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Constance Visovsky, PhD, RN, ACNP University of Nebraska
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000448645, CASE-CWRU-6Z03
Study First Received: December 7, 2005
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00263861     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
neurotoxicity
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Neurotoxicity Syndromes
Poisoning
Diabetes Mellitus
Disorders of Environmental Origin
Taxane

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on August 30, 2009