Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

Completed

• Conditions: Ototoxicity; Unspecified Childhood Solid Tumor, Protocol Specific

• Registration Number: NCT00458887
• Lead Sponsor: Children's Oncology Group

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.

Study Timeline

• Study First Submitted: 2007-04-09
• Study First Submitted QC: 2007-04-09
• Study First Posted: 2007-04-11
• Study Start: 2007-05
• Primary Completion: 2015-01
• Study Completion: 2017-02-28
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria	Length of study
Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations)	Length of Study
Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing	Length of study

Trial Locations

Locations (81)

UAB Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Childrens Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Southern California Permanente Medical Group; 🇺🇸 Los Angeles, California, United States

Children's Hospital Central California; 🇺🇸 Madera, California, United States

Lucile Packard Children's Hospital at Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Rady Children's Hospital - San Diego; 🇺🇸 San Diego, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

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