Overview

This trial is active, not recruiting.

Conditions neurotoxicity, unspecified adult solid tumor, protocol specific
Treatment management of therapy complications
Sponsor Case Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date November 2005
End date December 2012
Trial size 59 participants
Trial identifier NCT00305799, 10-05-19, CASE3Y05, P30CA043703

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Auditory and Vestibular Function Evaluation in Patients With Solid Tumors Treated With Oxaliplatin-Containing Chemotherapy
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Case Comprehensive Cancer Center.