Clinical Trial: Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Auditory and Vestibular Function Evaluation in Patients With Solid Tumors Treated With Oxaliplatin-Containing Chemotherapy
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 Summary:
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.
Sponsor: Case Comprehensive Cancer Center
Current Primary Outcome:
- 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 ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Case Comprehensive Cancer Center
Dates:
Date Received: March 21, 2006
Date Started: November 2005
Date Completion:
Last Updated: November 20, 2014
Last Verified: November 2014