Hearing Loss and Dizziness in Patients… | Clinical Trial

Key information

Conditions

Neurotoxicity Chemically-Induced Disorders Nervous System Diseases Neurotoxicity Syndromes Poisoning Unspecified Adult Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

management of therapy complications

Procedure

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.

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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2012
Study completion: 2014
First posted: Mar 22, 2006
Registry last updated: Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed