Nerve Changes in Patients Who Are Undergoing Chemotherapy or Biological Therapy for Cancer

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281853
• Other study ID #: CASE13Z04
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: N/A
• First received: January 24, 2006
• Last updated: June 10, 2010
• Start date: March 2005
• Est. completion date: August 2007

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neurotoxicity
• Neurotoxicity Syndromes
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• management of therapy complications
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.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment		baseline, and then weeks 4, 8, and 12 during study treatment	No
Primary	Vibratory sensation as measured by tuning fork at baseline, and then weeks 4, 8, and 12 during study treatment		baseline, and then weeks 4, 8, and 12 during study treatment	No
Primary	Blood pressure changes at baseline, and then weeks 4, 8, and 12 during study treatment		baseline, and then weeks 4, 8, and 12 during study treatment	No