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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00263861
First received: December 7, 2005
Last updated: June 10, 2010
Last verified: June 2010
  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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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 Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Cutaneous sensation as measured by Semmes-Weinstein monofilaments [ Time Frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Gait and balance as measured by Tinetti Performance Oriented Assessment of Gait and Balance Instrument [ Time Frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Vibration as measured by tuning fork [ Time Frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Lower extremity muscle strength as measured by Dynamometer [ Time Frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Blood pressure changes [ Time Frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Glycemic control as measured by Glycosylated Hemoglobin Assay [ Time Frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: March 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263861

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, 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 Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Constance Visovsky, PhD, RN, ACNP, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00263861     History of Changes
Other Study ID Numbers: CWRU6Z03, P30CA043703, CASE-CWRU-6Z03
Study First Received: December 7, 2005
Last Updated: June 10, 2010
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
neurotoxicity
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Chemically-Induced Disorders
Nervous System Diseases
Poisoning

ClinicalTrials.gov processed this record on November 20, 2014