Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00458887|
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : March 13, 2017
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.
|Condition or disease||Intervention/treatment|
|Ototoxicity Unspecified Childhood Solid Tumor, Protocol Specific||Procedure: management of therapy complications|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||301 participants|
|Official Title:||A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy|
|Study Start Date :||May 2007|
|Primary Completion Date :||January 2015|
|Study Completion Date :||February 28, 2017|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458887
Show 81 Study Locations
|Study Chair:||Lillian Sung, MD, PhD||The Hospital for Sick Children|