Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Case Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT00305799

First received: March 21, 2006

Last updated: November 27, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2006

Last Updated Date

November 27, 2012

Start Date ^ICMJE

November 2005

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00305799 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Condition ^ICMJE

Neurotoxicity
Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Procedure: management of therapy complications

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00305799

Other Study ID Numbers ^ICMJE

CASE3Y05, P30CA043703, CASE3Y05, 10-05-19

Has Data Monitoring Committee

Responsible Party

Case Comprehensive Cancer Center

Study Sponsor ^ICMJE

Case Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Sabarish Ayyappan, MD

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

Information Provided By

Case Comprehensive Cancer Center

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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