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Randomized Trial Comparison of Ototoxicity Monitoring Programs

NCT02099786 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-10-09

Study results available
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Summary

This study involves research. Some chemotherapeutic drugs that can permanently reduce hearing are termed "ototoxic". One such drug is the chemotherapy called cisplatin. Currently, if a patient is receiving cisplatin, hearing is tested in the Audiology Clinic using lengthy protocols and may be retested only when it is requested by their oncologist and when the Veteran can arrange an appointment. Researchers think that hearing testing prior to every treatment of cisplatin may reduce the number of Veterans who get disabling hearing loss from treatment. The purpose of this study is to compare the current method of monitoring hearing (audiology clinic protocols termed "usual care") with a new portable hearing monitoring program (a comprehensive program of ototoxicity monitoring termed "COMP-VA") that tests hearing using a portable hearing testing audiometer and a variety of efficient tools and techniques so that testing can occur prior to each cisplatin treatment at any quiet location in the hospital.

Conditions

Interventions

OTHER

COMP-VA

Hearing testing at each treatment interval by the comp-va audiologist

OTHER

Standard of care

Hearing testing done in the audiology clinic after oncology referral or patient self referral

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Dawn L Konrad-Martin, PhD · VA Portland Health Care System, Portland, OR

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2018-05-05
Completion
2018-05-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099786 on ClinicalTrials.gov