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


N/A
18 Years
N/A
Open (Enrolling)
Both
Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific

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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 CenterCleveland, Ohio  44109
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065