Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

Children's Oncology Group

Status: Completed

Conditions: Ototoxicity; Unspecified Childhood Solid Tumor, Protocol Specific

Treatments: Procedure: management of therapy complications

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00458887

ACCL05C1

COG-ACCL05C1 (Other Identifier)

CDR0000538247 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 301 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

301 participants in 1 patient group

Ancillary/Correlative (ototoxicity assessment)

Description:

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.

Treatment:

Procedure: management of therapy complications