Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00458887
First received: April 9, 2007
Last updated: May 30, 2013
Last verified: May 2013
  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
Study Design: Time Perspective: Prospective
Official Title: A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations) [ Time Frame: Length of Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 327
Study Start Date: May 2007
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary/Correlative (ototoxicity assessment)

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.

Procedure: management of therapy complications
Undergo hearing tests
Other Name: complications of therapy, management of

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer or planning to enroll on clinical trial ACCL0431

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458887

  Show 81 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Lillian Sung, MD, PhD The Hospital for Sick Children
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00458887     History of Changes
Other Study ID Numbers: ACCL05C1, COG-ACCL05C1, CDR0000538247
Study First Received: April 9, 2007
Last Updated: May 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
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 April 22, 2014