Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
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.
|Ototoxicity Unspecified Childhood Solid Tumor, Protocol Specific||Procedure: management of therapy complications|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy|
- 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 who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing [ Time Frame: Length of study ]
- Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations) [ Time Frame: Length of Study ]
|Study Start Date:||May 2007|
|Study Completion Date:||February 28, 2017|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Ancillary/Correlative (ototoxicity assessment)
Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) for management of therapy complications 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 for management of therapy complications before the transplantation and 4 weeks after transplantation.
Procedure: management of therapy complications
Undergo hearing tests
Other Name: complications of therapy, management of
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458887
Show 81 Study Locations
|Study Chair:||Lillian Sung, MD, PhD||The Hospital for Sick Children|