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


N/A
65 Years
N/A
Not Enrolling
Both
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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

Inclusion 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)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Cutaneous sensation as measured by Semmes-Weinstein monofilaments

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Constance Visovsky, PhD, RN, ACNP

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CWRU6Z03

NCT ID:

NCT00263861

Start Date:

March 2005

Completion Date:

September 2007

Related Keywords:

  • Neurotoxicity
  • Unspecified Adult Solid Tumor, Protocol Specific
  • neurotoxicity
  • unspecified adult solid tumor, protocol specific
  • Neurotoxicity Syndromes
  • Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065