An interventional study of COMP-VA and Standard of care in Cisplatin Ototoxicity and Hearing Loss, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-09.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Prevention
Among 16 studies in Hearing Loss by VA Office of Research and Development — 3 open to participants now, 3 under way, none of them phase 3. Hearing Loss · VA Office of Research and Development.
Among the 16 studies in Hearing Loss by VA Office of Research and Development, this one is the 11th largest by enrollment of the 13 interventional ones, is one of 2 that started in 2015, is one of 13 with no phase, and was the 8th registered.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 47 is close to the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →3 of the 16 studies in Hearing Loss by VA Office of Research and Development are open now, in 1 country. Each count lists the studies.
Of the 122 Hearing Loss studies recruiting now, 58 (48%) set no upper age limit and 42 (34%) stop at 75 or younger; 46 take children under 18; 46 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · healthy volunteers too.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2015.
Median enrollment 84 across the 13 interventional studies, 63 across the 3 observational. Of the 12 that completed or were terminated, 10 (83%) have results posted.
VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
1 of the studies in Hearing Loss by VA Office of Research and Development that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05028972VA Office of Research and DevelopmentHearing Impairment, Strategies and Outcomes in VA Emergency Departments | 2027-03-31 |
Among the 16 studies in Hearing Loss by VA Office of Research and Development, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Criteria for excluding subjects (chemotherapy and controls subjects) from this study will be:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hearing testing at each treatment and at 1 month following treatment.
Other: COMP-VA
Hearing testing done according to Audiology Clinic protocol
Other: Standard of care
Hearing testing at each treatment interval by the comp-va audiologist
Hearing testing done in the audiology clinic after oncology referral or patient self referral
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 1 year post randomization
Forty-seven Veterans receiving cisplatin for the treatment of cancer were randomized to one of the two treatment arms of the clinical trial. Thirty-six healthy participants were studied to assess normal variability in auditory function measures over time; they were not part of the clinical trial portion of this research project.
| Milestone | COMP-VA | Usual Care |
|---|---|---|
| Started | 24 | 23 |
| Program eval 1 | 24 | 23 |
| Program eval 2 | 23 | 19 |
| Program eval 3 | 21 | 15 |
| Completed | 21 | 15 |
| Not completed | 3 | 8 |
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
| Participants | COMP-VA | Usual Care |
|---|---|---|
| Number of Participants With an Ototoxic Hearing Shift | 15 | 8 |
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.
| Participants | COMP-VA | Usual Care |
|---|---|---|
| Number of Participants Who Accessed the Audiology Clinic for Aural Rehabilitation | 12 | 12 |
Mortality among participants defined as differences in rates of death within one year of randomization.
| Participants | COMP-VA | Usual Care |
|---|---|---|
| Number of Participants With Mortality | 2 | 4 |
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
| score on a scale | COMP-VA | Usual Care |
|---|---|---|
| Hearing-related Quality of Life Measure | 20.8 ± 18.6 | 23.2 ± 22.5 |
Collected over 4 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| COMP-VA | 2/24 (8.3%) | 0/24 (0%) | 0/24 (0%) |
| Usual Care | 4/23 (17.4%) | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(years) | COMP-VA | Usual Care | Total |
|---|---|---|---|
| Mean | 64.6 ± 6.4 | 64.7 ± 9.1 | 64.6 ± 7.8 |
| Sex: Female, Male(Participants) | COMP-VA | Usual Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 24 | 23 | 47 |
| Race and Ethnicity Not Collected(Participants) | COMP-VA | Usual Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| 3, 4, and 6 kHz pure tone average (PTA)(dB HL) | COMP-VA | Usual Care | Total |
|---|---|---|---|
| Mean | 47.8 ± 21.5 | 55.4 ± 19.8 | 51.6 ± 20.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
VA Office of Research and Development →