Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
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Purpose
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 | Intervention |
|---|---|
|
Ototoxicity Unspecified Childhood Solid Tumor, Protocol Specific |
Procedure: management of therapy complications |
| Study Type: | Observational |
| 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
- Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing
- Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations)
| Estimated Enrollment: | 327 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer
- Treatment does not need to be on a COG therapeutic study
- Planning to enroll on clinical trial ACCL0431
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior cisplatin
Contacts and Locations
Show 81 Study Locations| Study Chair: | Lillian Sung, MD, PhD | The Hospital for Sick Children |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00458887 History of Changes |
| Other Study ID Numbers: | CDR0000538247, COG-ACCL05C1 |
| Study First Received: | April 9, 2007 |
| Last Updated: | October 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
ototoxicity unspecified childhood solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Cisplatin Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013