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Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin

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ClinicalTrials.gov Identifier: NCT00458887
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Ototoxicity Unspecified Childhood Solid Tumor, Protocol Specific Procedure: management of therapy complications

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.


Study Design

Study Type : Observational
Actual Enrollment : 301 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy
Study Start Date : May 2007
Primary Completion Date : January 2015
Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria [ Time Frame: Length of study ]
  2. Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing [ Time Frame: Length of study ]
  3. Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations) [ Time Frame: Length of Study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458887


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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00458887     History of Changes
Other Study ID Numbers: ACCL05C1
COG-ACCL05C1 ( Other Identifier: Children's Oncology Group )
CDR0000538247 ( Other Identifier: Clinical Trials.gov )
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Children's Oncology Group:
ototoxicity
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Cisplatin
Antineoplastic Agents