Clinical trial NCT00263861: Nerve Function in Older Diabetic Patients Who Are Undergoing Chemotherapy for Metastatic Solid Tumors
Official title: Impact of Treatment With Taxane or Platinum-Containing Regimens on Peripheral Nerve Functioning in Older Cancer Patients With Diabetes: An Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurotoxicity
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: neurotoxicity
unspecified adult solid tumor, protocol specific
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-12-09
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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)

Primary outcomes:
measure: Cutaneous sensation as measured by Semmes-Weinstein monofilaments
timeFrame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
measure: Gait and balance as measured by Tinetti Performance Oriented Assessment of Gait and Balance Instrument
timeFrame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
measure: Vibration as measured by tuning fork
timeFrame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
measure: Lower extremity muscle strength as measured by Dynamometer
timeFrame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
measure: Blood pressure changes
timeFrame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
measure: Glycemic control as measured by Glycosylated Hemoglobin Assay
timeFrame: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Constance Visovsky, PhD, RN, ACNP
role: PRINCIPAL_INVESTIGATOR
References: