Patient Care | Clinical Trials | Trial

Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

Conditions

Ototoxicity | Unspecified Childhood Solid Tumor, Protocol Specific

Trial Phase

N/A

Trial Purpose and Description

Trial 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.


Trial 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.

Participation Guidelines

Age:
1 Year - 18 Years
Gender:
Both

Eligibility 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
Sponsor:
Children's Oncology Group
National Cancer Institute (NCI)
Dates:
May 2007
Last Updated:
May 4, 2012
Study HIC#:
1101007858

Clinicaltrials.gov ID: NCT00458887