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Trial Outcomes & Findings for Randomized Trial Comparison of Ototoxicity Monitoring Programs (NCT NCT02099786)

NCT ID: NCT02099786

Last Updated: 2019-10-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

35 days post randomization

Results posted on

2019-10-09

Participant Flow

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.

Participant milestones

Participant milestones
Measure
COMP-VA
Hearing testing at each treatment and at 1 month following treatment. COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist
Usual Care
Hearing testing done according to Audiology Clinic protocol Standard of care: Hearing testing done in the audiology clinic after oncology referral
Overall Study
STARTED
24
23
Overall Study
Program Eval 1
24
23
Overall Study
Program Eval 2
23
19
Overall Study
Program Eval 3
21
15
Overall Study
COMPLETED
21
15
Overall Study
NOT COMPLETED
3
8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
COMP-VA
n=24 Participants
Hearing testing at each treatment and at 1 month following treatment. COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist
Usual Care
n=23 Participants
Hearing testing done according to Audiology Clinic protocol Standard of care: Hearing testing done in the audiology clinic after oncology referral
Total
n=47 Participants
Total of all reporting groups
Age, Continuous
64.6 years
STANDARD_DEVIATION 6.4 • n=24 Participants
64.7 years
STANDARD_DEVIATION 9.1 • n=23 Participants
64.6 years
STANDARD_DEVIATION 7.8 • n=47 Participants
Sex: Female, Male
Female
0 Participants
n=24 Participants
0 Participants
n=23 Participants
0 Participants
n=47 Participants
Sex: Female, Male
Male
24 Participants
n=24 Participants
23 Participants
n=23 Participants
47 Participants
n=47 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
3, 4, and 6 kHz pure tone average (PTA)
47.8 dB HL
STANDARD_DEVIATION 21.5 • n=24 Participants
55.4 dB HL
STANDARD_DEVIATION 19.8 • n=23 Participants
51.6 dB HL
STANDARD_DEVIATION 20.8 • n=47 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
COMP-VA
n=21 Participants
Hearing testing at each treatment and at 1 month following treatment. COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist
Usual Care
n=15 Participants
Hearing testing done according to Audiology Clinic protocol Standard of care: Hearing testing done in the audiology clinic after oncology referral
Number of Participants With an Ototoxic Hearing Shift
15 Participants
8 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 1 year post randomization

Population: All participants who received at least one dose of cisplatin and had at least two Program Evaluations.

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.

Outcome measures

Outcome measures
Measure
COMP-VA
n=24 Participants
Hearing testing at each treatment and at 1 month following treatment. COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist
Usual Care
n=23 Participants
Hearing testing done according to Audiology Clinic protocol Standard of care: Hearing testing done in the audiology clinic after oncology referral
Number of Participants Who Accessed the Audiology Clinic for Aural Rehabilitation
12 Participants
12 Participants

PRIMARY outcome

Timeframe: 1 year post randomization

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

Outcome measures

Outcome measures
Measure
COMP-VA
n=24 Participants
Hearing testing at each treatment and at 1 month following treatment. COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist
Usual Care
n=23 Participants
Hearing testing done according to Audiology Clinic protocol Standard of care: Hearing testing done in the audiology clinic after oncology referral
Number of Participants With Mortality
2 Participants
4 Participants

PRIMARY outcome

Timeframe: 1 year post randomization

Population: Missing data on some participants due to loss of follow up.

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

Outcome measures

Outcome measures
Measure
COMP-VA
n=21 Participants
Hearing testing at each treatment and at 1 month following treatment. COMP-VA: Hearing testing at each treatment interval by the comp-va audiologist
Usual Care
n=15 Participants
Hearing testing done according to Audiology Clinic protocol Standard of care: Hearing testing done in the audiology clinic after oncology referral
Hearing-related Quality of Life Measure
20.8 score on a scale
Standard Deviation 18.6
23.2 score on a scale
Standard Deviation 22.5

Adverse Events

COMP-VA

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dawn Konrad-Martin

VA RR&D National Center for Rehabilitative Auditory Research

Phone: 503-220-8262

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place