A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ototoxicity
- Sponsor
- Children's Oncology Group
- Enrollment
- 301
- Locations
- 81
- Primary Endpoint
- Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
RATIONALE: New ways to find out about hearing loss after treatment with chemotherapy may improve the ability to plan cancer treatment and may help patients live more comfortably.
PURPOSE: This clinical trial is assessing ear damage in young cancer patients treated with cisplatin.
Detailed Description
OBJECTIVES: * Determine the optimal criteria for determination of ototoxicity in younger cancer patients treated with cisplatin. * Determine the feasibility of including ultrahigh frequency and evoked otoacoustic emission testing as adjunctive measures of ototoxicity. * Determine the feasibility and necessity of central review of audiometry data. OUTLINE: This is a multicenter, prospective, cohort study. Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) before the first course of planned cisplatin, before each subsequent course of cisplatin, and 4 weeks after the last dose of cisplatin. Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation undergo hearing tests before the transplantation and 4 weeks after transplantation. PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria
Time Frame: Length of study
Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations)
Time Frame: Length of Study
Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing
Time Frame: Length of study