Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
- Conditions
- OtotoxicityUnspecified Childhood Solid Tumor, Protocol Specific
- Interventions
- Procedure: management of therapy complications
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 301
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary/Correlative (ototoxicity assessment) management of therapy complications 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.
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (81)
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Nemours Children's Clinic - Pensacola
🇺🇸Pensacola, Florida, United States
Southern California Permanente Medical Group
🇺🇸Los Angeles, California, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Geisinger Cancer Institute at Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Lehigh Valley Hospital - Muhlenberg
🇺🇸Bethlehem, Pennsylvania, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸Miami, Florida, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Masonic Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Legacy Emanuel Children's Hospital
🇺🇸Portland, Oregon, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Cardinal Glennon Children's Hospital
🇺🇸St. Louis, Missouri, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
Tulane Cancer Center Office of Clinical Research
🇺🇸Alexandria, Louisiana, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
Helen DeVos Children's Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
🇺🇸Summit, New Jersey, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
Knight Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
National Naval Medical Center
🇺🇸Bethesda, Maryland, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Lucile Packard Children's Hospital at Stanford University Medical Center
🇺🇸Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Nemours Children's Clinic - Orlando
🇺🇸Orlando, Florida, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Rhode Island Hospital Comprehensive Cancer Center
🇺🇸Providence, Rhode Island, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Riley's Children Cancer Center at Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Children's and Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia