NCT02872844

Brief Summary

This pilot study plans to determine whether or not local heat-stress as a mechanism can help to preserve hearing in adults treated with Cisplatin.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 3, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

2.1 years

First QC Date

August 16, 2016

Last Update Submit

August 17, 2023

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Audiometric Effect

    Audiometric evaluation will serve as the primary measure of outcome.

    One year

Study Arms (1)

Heat-stress

EXPERIMENTAL

Each participant will undergo a 30-minute heat stress to one randomized ear. The participant will be reclined and the hot air caloric at 50°C applied by a licensed, unblinded audiologist for 30 minutes.

Device: ICS AirCal3

Interventions

ICS AirCal3DEVICE

Each patient will undergo a 30-minute heat stress to one ear. For randomization, the left ear will be treated in patients with a registration number ending with an odd number and the right for even numbers. An ICS AirCal3 Research Strategy (Otometrics) system attached to an Intel Core 15vPro Thinkpad (IBM) laptop is used within the audiometry department of a separate outpatient clinic. The patients will be reclined and the hot air caloric at 50°C applied by a licensed, unblinded audiologist for 30 minutes. The patients will be allowed to fixate and use whatever means they prefer for entertainment during the intervention.

Heat-stress

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient undergoing total cisplatin in total doses \> 100mg/m2.
  • Written consent.
  • Age \> 19 years.

You may not qualify if:

  • Inability to tolerate the intervention
  • Exposure to cisplatin treatment without intervention.
  • Head and neck carcinoma
  • Baseline asymmetric hearing loss.
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul Judge, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

November 3, 2016

Primary Completion

December 13, 2018

Study Completion

December 13, 2018

Last Updated

August 22, 2023

Record last verified: 2023-08