Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors

Completed

• Conditions: Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00305799
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-22
• Primary Completion: 2012-12
• Status Verified: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States