N/A
N=47
Randomized Trial Comparison of Ototoxicity Monitoring Programs
Cisplatin Ototoxicity · Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT02099786 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With an Ototoxic Hearing Shift — 15; 8 Participants — p=.27
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- COMP-VA (Other); Standard of care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Ototoxic Hearing Shift |
15; 8 | .27 |
| PRIMARY Number of Participants Who Accessed the Audiology Clinic for Aural Rehabilitation |
12; 12 | .88 |
| PRIMARY Number of Participants With Mortality |
2; 4 | — |
| PRIMARY Hearing-related Quality of Life Measure |
20.8; 23.2 | .72 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02099786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.