Randomized Trial Comparison of Ototoxicity Monitoring Programs

NCT02099786 | Completed Results

• 2 other identifiers: C0239-R3114
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Cisplatin Ototoxicity; Hearing Loss

Keywords

hearing; cisplatin; Ototoxicity; Veterans

Outcome Measures

Primary Outcomes (4)

• Number of Participants With an Ototoxic Hearing Shift

  Veterans randomized to the COMP-VA arm will have improved hearing outcomes (a) fewer ASHA-significant threshold shifts, (b) fewer CTCAE grade 1 or greater hearing shifts at Program Evaluation 3 as compared with Veterans randomized to the Usual Care arm. 1. ASHA Shift is defined as: 20 dB shift at a single frequency 10 dB shift at two adjacent frequencies loss of response at three adjacent frequencies 2. CTCAE Grade 1 or greater ototoxicity = hearing shift of 15-25 dB averaged at 2 contiguous test frequencies

  35 days post randomization

• Number of Participants Who Accessed the Audiology Clinic for Aural Rehabilitation

  Veterans randomized to Comp-VA will access and use audiology rehabilitation at higher rates than usual care up to 1 year post-treatment. This includes: New hearing aid issued; Hearing aid adjustments made; Technology updated.

  through study completion, an average of 1 year post randomization

• Number of Participants With Mortality

  Mortality among participants defined as differences in rates of death within one year of randomization.

  1 year post randomization

• Hearing-related Quality of Life Measure

  Differences in the Hearing Handicap Inventory for Adults (HHIA) questionnaire score \[or Hearing Handicap Inventory for the Elderly (HHIE) score as appropriate\] depending on the age of the subject. Minimum possible value = 0 Maximum possible value = 100 A higher score indicates poorer performance

  1 year post randomization

Study Arms (2)

COMP-VA

EXPERIMENTAL

Hearing testing at each treatment and at 1 month following treatment.

Other: COMP-VA

Usual Care

EXPERIMENTAL

Hearing testing done according to Audiology Clinic protocol

Other: Standard of care

Interventions

COMP-VA OTHER

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

COMP-VA

Standard of care OTHER

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

Usual Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Veterans entering cisplatin chemotherapy will be informed of the project and invited to participate unless the Veteran was excluded by CPRS review or medical advice.

You may not qualify if:

• Experimental subjects must be prescribed cisplatin for treatment of cancer to be enrolled in the treatment arms of this study.
• Criteria for excluding subjects (chemotherapy and controls subjects) from this study will be:
• cognitively or physically unable to participate (patient or nurse report patient is incapable of participating), CPRS indication that subject exhibits aggressive behavior, subject has documented dementia, Alzheimer's disease, or severe psychosocial disorder, CPRS notes indicate individual is not legally capable of providing informed consent (subject has a legal guardian)
• unable to provide reliable behavioral hearing test responses (for either program evaluation hearing test or baseline, pre -treatment hearing test) as indicated by intra-session behavioral threshold reliability criterion of \> +5 dB)
• exhibits Meniere's disease or retrocochlear disorder based on hearing test results, patient report or notes in CPRS
• exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, patient report, or notes in CPRS
• unwilling to participate

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (8)

• Brungart D, Schurman J, Konrad-Martin D, Watts K, Buckey J, Clavier O, Jacobs PG, Gordon S, Dille MF. Using tablet-based technology to deliver time-efficient ototoxicity monitoring. Int J Audiol. 2018 Sep;57(sup4):S25-S33. doi: 10.1080/14992027.2017.1370138. Epub 2017 Sep 12.

  PMID: 28893111 BACKGROUND

• Dille MF, McMillan GP, Helt WJ, Konrad-Martin D, Jacobs P. A Store-and-Forward Tele-Audiology Solution to Promote Efficient Screenings for Ototoxicity during Cisplatin Cancer Treatment. J Am Acad Audiol. 2015 Oct;26(9):750-60. doi: 10.3766/jaaa.15028.

  PMID: 26415968 BACKGROUND

• Reavis KM, McMillan GP, Dille MF, Konrad-Martin D. Meta-Analysis of Distortion Product Otoacoustic Emission Retest Variability for Serial Monitoring of Cochlear Function in Adults. Ear Hear. 2015 Sep-Oct;36(5):e251-60. doi: 10.1097/AUD.0000000000000176.

  PMID: 25985018 BACKGROUND

• Konrad-Martin D, Knight K, McMillan GP, Dreisbach LE, Nelson E, Dille M. Long-Term Variability of Distortion-Product Otoacoustic Emissions in Infants and Children and Its Relation to Pediatric Ototoxicity Monitoring. Ear Hear. 2020 Mar/Apr;41(2):239-253. doi: 10.1097/AUD.0000000000000536.

  PMID: 29280917 BACKGROUND

• Konrad-Martin D, Poling GL, Garinis AC, Ortiz CE, Hopper J, O'Connell Bennett K, Dille MF. Applying U.S. national guidelines for ototoxicity monitoring in adult patients: perspectives on patient populations, service gaps, barriers and solutions. Int J Audiol. 2018 Sep;57(sup4):S3-S18. doi: 10.1080/14992027.2017.1398421. Epub 2017 Nov 20.

  PMID: 29157038 BACKGROUND

• Garinis AC, Cornell A, Allada G, Fennelly KP, Maggiore RJ, Konrad-Martin D. Ototoxicity monitoring through the eyes of the treating physician: Perspectives from pulmonology and medical oncology. Int J Audiol. 2018 Sep;57(sup4):S19-S24. doi: 10.1080/14992027.2017.1381769. Epub 2017 Oct 5.

  PMID: 28978238 BACKGROUND

• Konrad-Martin D, Poling GL, Dreisbach LE, Reavis KM, McMillan GP, Lapsley Miller JA, Marshall L. Serial Monitoring of Otoacoustic Emissions in Clinical Trials. Otol Neurotol. 2016 Sep;37(8):e286-94. doi: 10.1097/MAO.0000000000001134.

  PMID: 27518137 BACKGROUND

• Konrad-Martin D, Reavis KM, McMillan G, Helt WJ, Dille M. Proposed comprehensive ototoxicity monitoring program for VA healthcare (COMP-VA). J Rehabil Res Dev. 2014;51(1):81-100. doi: 10.1682/JRRD.2013.04.0092.

  PMID: 24805896 BACKGROUND

MeSH Terms

Conditions

Hearing Loss; Ototoxicity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Dawn Konrad-Martin
• Organization: VA RR&D National Center for Rehabilitative Auditory Research

dawn.martin@va.gov

503-220-8262

Study Officials

• Dawn L Konrad-Martin, PhD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 31, 2014
• Study Start: April 1, 2015
• Primary Completion: May 5, 2018
• Study Completion: May 5, 2018
• Last Updated: October 9, 2019
• Results First Posted: October 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)