Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors - Full Text View

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00305799

Purpose

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.

Condition	Intervention
Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific	Procedure: management of therapy complications

Study Type:	Observational
Official Title:	Auditory and Vestibular Function Evaluation in Patients With Solid Tumors Treated With Oxaliplatin-Containing Chemotherapy

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Cancer Dizziness and Vertigo Hearing Disorders and Deafness Peripheral Nerve Disorders

Drug Information available for: Oxaliplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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
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

Estimated Enrollment:	60
Study Start Date:	November 2005
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305799

Locations

United States, Ohio
Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Panos Savvides, MD

Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000465215, CASE-3Y05, CASE-100519
Study First Received:	March 21, 2006
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00305799 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

neurotoxicity
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Oxaliplatin
Deafness
Neurotoxicity Syndromes
Dizziness

Poisoning
Disorders of Environmental Origin
Hearing Loss

Additional relevant MeSH terms:

Oxaliplatin
Neurotoxicity Syndromes
Antineoplastic Agents
Therapeutic Uses

Nervous System Diseases
Poisoning
Disorders of Environmental Origin
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 24, 2009