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Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors

Case Comprehensive Cancer Center (Case CCC) logo

Case Comprehensive Cancer Center (Case CCC)

Status

Completed

Conditions

Unspecified Adult Solid Tumor, Protocol Specific
Neurotoxicity

Treatments

Procedure: management of therapy complications

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00305799
CASE3Y05 (Other Identifier)
P30CA043703 (U.S. NIH Grant/Contract)
10-05-19 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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