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Completed

NCT Number: NCT00263861

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5047, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

management of therapy complications

Procedure

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.

Primary outcomes

  1. 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

  2. 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

  3. Vibration as measured by tuning fork

    Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment

  4. 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

  5. Blood pressure changes

    Time frame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment

  6. 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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 9, 2005
Registry last updated
Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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