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Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

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

Genetics Home Reference related topics:   nonsyndromic deafness   

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

ChemIDplus related topics:   Oxaliplatin   

U.S. FDA Resources

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

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

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

Study ID Numbers:   CDR0000465215, CASE-3Y05, CASE-100519
First Received:   March 21, 2006
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00305799
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
Neurotoxicity syndromes
Poisoning
Disorders of Environmental Origin
Hearing Loss

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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