Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors

Case Comprehensive Cancer Center59 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific

Interventions

management of therapy complicationsPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of solid tumor * Received an oxaliplatin-containing chemotherapy regimen within the past 15 months\* NOTE: \*If oxaliplatin was omitted from the patient's most recent chemotherapy regimen due to ototoxicity, the patient is still eligible for participation in this study * No known CNS metastases PATIENT CHARACTERISTICS: * No history of spinal injuries * ECOG performance status 0-3 * No history of chronic renal failure * No known HIV/AIDS PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Locations (2)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

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

Data from ClinicalTrials.gov

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