Cisplatin OtotoxicityCOMP-VANCT02099786
Randomized Trial Comparison of Ototoxicity Monitoring Programs
A study testing COMP-VA in people with Cisplatin Ototoxicity and Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cisplatin Ototoxicity, Hearing Loss
- What is being tested?
- COMP-VA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 5 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
Official title: Comprehensive Ototoxicity Monitoring Program for VA: A Randomized Trial
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.
Read the 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.
- Conditions
- Cisplatin Ototoxicity, Hearing Loss
- Being tested
- COMP-VA, Standard of care
- Keywords
- hearing, cisplatin, Ototoxicity, Veterans
- Medical subject headings
- Hearing Loss, Ototoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMP-VAOther
Hearing testing at each treatment interval by the comp-va audiologist
Standard of careOther
Hearing testing done in the audiology clinic after oncology referral or patient self referral
| Study group | Role | What they receive |
|---|---|---|
| COMP-VA | Experimental | Hearing testing at each treatment and at 1 month following treatment. Receives: Other: COMP-VA |
| Usual Care | Experimental | Hearing testing done according to Audiology Clinic protocol Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
- CTCAE Grade 1 or greater ototoxicity = hearing shift of 15-25 dB averaged at 2 contiguous test frequencies
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 year post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study start1 Apr 2015
- Primary completion5 May 2018
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cisplatin OtotoxicityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dawn L Konrad-Martin, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099786
- Sponsor's protocol ID
- C0239-R
- Other IDs
- 3114
- Acronym
- COMP-VA
- Status last verified
- Sep 2019
- First submitted
- 26 Feb 2014
- Last updated
- 9 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28893111Dille 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.
PubMed 26415968Reavis 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.
PubMed 25985018Konrad-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.
PubMed 29280917Konrad-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.
PubMed 29157038Garinis 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.
PubMed 28978238Konrad-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.
PubMed 27518137Konrad-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.
PubMed 24805896
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Ototoxicity Monitoring Program for VA: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02099786
- Acronym / sponsor ID
- COMP-VA / C0239-R
- Conditions
- Cisplatin Ototoxicity, Hearing Loss
- Keywords
- hearing, cisplatin, Ototoxicity, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Posted 9 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMP-VA | Experimental | Other: COMP-VAHearing testing at each treatment and at 1 month following treatment. |
| Usual Care | Experimental | Other: Standard of careHearing testing done according to Audiology Clinic protocol |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMP-VAHearing testing at each treatment interval by the comp-va audiologist | Other | COMP-VA |
| Standard of careHearing testing done in the audiology clinic after oncology referral or patient self referral | Other | Usual Care |
Primary outcome
Number of Participants With an Ototoxic Hearing Shift
Time frame: 35 days post randomization
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
Number of Participants Who Accessed the Audiology Clinic for Aural Rehabilitation
Time frame: through study completion, an average of 1 year post randomization
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.
Number of Participants With Mortality
Time frame: 1 year post randomization
Mortality among participants defined as differences in rates of death within one year of randomization.
Hearing-related Quality of Life Measure
Time frame: 1 year post randomization
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28893111Brungart 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.
- Background: PubMed 26415968Dille 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.
- Background: PubMed 25985018Reavis 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.
- Background: PubMed 29280917Konrad-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.
- Background: PubMed 29157038Konrad-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.
- Background: PubMed 28978238Garinis 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.
- Background: PubMed 27518137Konrad-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.
- Background: PubMed 24805896Konrad-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn L Konrad-Martin, PhD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMP-VA in people with Cisplatin Ototoxicity and Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Ototoxic Hearing Shift (time frame: 35 days post randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099786, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.