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Clinical Trials/NCT00305799
NCT00305799
Completed
Not Applicable

Auditory and Vestibular Function Evaluation in Patients With Solid Tumors Treated With Oxaliplatin-Containing Chemotherapy

Case Comprehensive Cancer Center2 sites in 1 country59 target enrollmentNovember 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurotoxicity
Sponsor
Case Comprehensive Cancer Center
Enrollment
59
Locations
2
Primary Endpoint
Hearing loss as measured by Hearing Loss Inventory, Dizziness Handicap Inventory, and audiogram every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

RATIONALE: Understanding how oxaliplatin affects hearing loss, dizziness, and peripheral neuropathy may improve the ability to plan effective treatment for patients receiving oxaliplatin for solid tumors.

PURPOSE: This clinical trial is studying hearing loss and dizziness in patients receiving oxaliplatin for solid tumors.

Detailed Description

OBJECTIVES: * Define the prevalence of audiometrically detectable hearing loss in patients with solid tumors treated with oxaliplatin. * Describe the association of chemotherapy-induced peripheral neuropathy (CIPN) and audiometrically detectable hearing loss in these patients. * Describe the association of CIPN and patient self-reported scales including, Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory. OUTLINE: This is an exploratory study. Patients will complete three self-reported questionnaires including the Peripheral Neuropathy Scale, Hearing Handicap Inventory for Adults, and Dizziness Handicap Inventory. Patients will also be asked a series of questions regarding symptoms or complaints about hearing changes, tinnitus, and dizziness that they may have experienced prior to, during, and after completion of chemotherapy. Patients will also undergo a hearing test. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
November 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hearing loss as measured by Hearing Loss Inventory, Dizziness Handicap Inventory, and audiogram every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment

Time Frame: every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment

Peripheral neuropathy as measured by Peripheral Neuropathy Scale every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment

Time Frame: every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment

Study Sites (2)

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