Clinical trial NCT02099786: Randomized Trial Comparison of Ototoxicity Monitoring Programs
Official title: Comprehensive Ototoxicity Monitoring Program for VA: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cisplatin Ototoxicity
Hearing Loss
Keywords: hearing
cisplatin
Ototoxicity
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-03-31
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Research objectives are to compare the effectiveness of ototoxicity monitoring implemented using Comp-VA or usual care with regard to (1) improving Veterans' hearing and quality of life outcomes, (2) assisting oncologists in pre-treatment counseling and therapeutic planning and (3) increasing use of post-treatment rehabilitative services.

The investigators plan to recruit a total of 320 Veterans undergoing cisplatin chemotherapeutic treatment over 4 years and 120 control subjects.

Program Evaluation: Hearing testing prior to treatment will be done in order to establish eligibility, enroll and randomize each subject into one of two study arms. At 5 weeks and at one year post-randomization hearing will be re-tested in order to obtain an estimate of longitudinal trends in hearing and quality of life assessment. Use of audiological services following treatment from the randomized subjects will be tracked. Finally, data will also be collected at each treatment interval to track use of counseling tools and oncology personnel treatment decisions.

Serial measurements from subjects receiving cisplatin prior to treatment who are randomized to:

Comp-VA group will get a screening hearing test prior to treatment, at each treatment interval and at one-month post-treatment. Auditory testing will be done on or near the Chemo Unit and will include otoscopy, immittance testing, and a hearing testing done by the Veteran using a self-testing procedure, and may be tested using distortion product otoacoustic emissions (DPOAEs), if they cannot take a reliable hearing test.

Usual care group will receive a full audiometric evaluation (otoscopy, immittance testing, air conduction and bone conduction hearing testing, speech audiometry, and distortion product otoacoustic emissions, DPOAEs) scheduled in the audiology clinic sound booth according to Audiology Service ototoxicity monitoring protocols. Testing will be arranged according to availability of appointments and patient convenience.

Additionally data will also be collected from control subjects who are similar in age and are tested at intervals similar to the chemotherapy subjects.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* 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
* hearing thresholds \> 70 dB SPL at 4 kHz and below (based on DPOAE 'no response' data from a similar protocol described in Bibliography Reference 32, Table 3). The last exclusion was adopted in an effort to increase the potential that DPOAEs will be measurable in a large number of subjects.

Primary outcomes:
measure: Number of Participants With an Ototoxic Hearing Shift
timeFrame: 35 days post randomization
measure: Number of Participants Who Accessed the Audiology Clinic for Aural Rehabilitation
timeFrame: through study completion, an average of 1 year post randomization
measure: Number of Participants With Mortality
timeFrame: 1 year post randomization
measure: Hearing-related Quality of Life Measure
timeFrame: 1 year post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Dawn L Konrad-Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.