Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00305799
First received: March 21, 2006
Last updated: December 19, 2013
Last verified: December 2013
  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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Auditory and Vestibular Function Evaluation in Patients With Solid Tumors Treated With Oxaliplatin-Containing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

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 [ 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 ]

Enrollment: 59
Study Start Date: November 2005
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: management of therapy complications
    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.
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
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

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 Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Sabarish Ayyappan, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00305799     History of Changes
Other Study ID Numbers: CASE3Y05, P30CA043703, CASE3Y05, 10-05-19
Study First Received: March 21, 2006
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
neurotoxicity
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Neoplasms
Nervous System Diseases
Poisoning
Substance-Related Disorders
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014