Auditory and Vestibular Function Evaluation in Patients With Solid Tumors Treated With Oxaliplatin-Containing Chemotherapy
18 Years
N/A
Both
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Auditory and Vestibular Function Evaluation in Patients With Solid Tumors Treated With Oxaliplatin-Containing Chemotherapy
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.
Inclusion 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
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
Outcome Time Frame:
every 2 months during treatment, and then 2-4 weeks and 6 months after completion of study treatment
Safety Issue:
No
Principal Investigator
Sabarish Ayyappan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CASE3Y05
NCT ID:
NCT00305799
Start Date:
November 2005
Completion Date:
Related Keywords:
- Neurotoxicity
- Unspecified Adult Solid Tumor, Protocol Specific
- neurotoxicity
- unspecified adult solid tumor, protocol specific
- Neurotoxicity Syndromes
- Neoplasms
Name | Location |
|---|---|
| MetroHealth Medical Center | Cleveland, Ohio 44109 |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
