Clinical trial NCT00281853: Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer
Official title: Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures
Study type: OBSERVATIONAL
Overall status: COMPLETED
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: 2006-01-25
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are receiving chemotherapy or biological therapy for cancer.

Brief summary: RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve function may help doctors plan treatment and help patients live more comfortably.

PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving chemotherapy or biological therapy for cancer.

Detailed description: OBJECTIVES:

* Determine the change in peripheral nerve function in cancer patients during and after treatment with chemotherapy or biologic therapy.
* Determine the clinical measurement of hearing-related air and bone conduction and vibratory sensation in these patients.
* Correlate the changes in orthostatic blood pressure using both the Vasotrac automated blood pressure device and the standard clinical automated blood pressure equipment.
* Determine the patient's perception of hearing quality before and after treatment with chemotherapy or biologic therapy.

OUTLINE: This is a multicenter study.

Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of cancer
* Scheduled to be treated with 1 of the following agents:

  * Cisplatin/paclitaxel combination
  * Biologic therapy with high-dose interferon alfa

PATIENT CHARACTERISTICS:

* Normal vision OR vision corrected with glasses or contact lenses
* No diseases or disorders reducing peripheral nerve function, including any of the following:

  * Diabetes mellitus
  * HIV/AIDS
  * Uremia
  * Spinal injuries
  * Alcoholism
  * CNS problems
* No hearing impairment

PRIOR CONCURRENT THERAPY:

* No prior biologic therapy or neurotoxic chemotherapy

Primary outcomes:
measure: Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment
timeFrame: baseline, and then weeks 4, 8, and 12 during study treatment
measure: Vibratory sensation as measured by tuning fork at baseline, and then weeks 4, 8, and 12 during study treatment
timeFrame: baseline, and then weeks 4, 8, and 12 during study treatment
measure: Blood pressure changes at baseline, and then weeks 4, 8, and 12 during study treatment
timeFrame: baseline, and then weeks 4, 8, and 12 during 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
role: PRINCIPAL_INVESTIGATOR
References: