Hearing LossNCT02872844
Local Heat-Stress as a Mechanism of Hearing Preservation
A study testing ICS AirCal3 in people with Hearing Loss, run by University of Nebraska.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- ICS AirCal3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2016to 13 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient undergoing total cisplatin in total doses > 100mg/m2.
- Written consent.
- Age > 19 years.
Who cannot join
- Inability to tolerate the intervention
- Exposure to cisplatin treatment without intervention.
- Head and neck carcinoma
- Baseline asymmetric hearing loss.
- Pregnant or breastfeeding women.
About this study
Official title: Local Heat-Stress as a Mechanism of Hearing Preservation in Adults Treated With Cisplatin: A Pilot Study
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.
Read the detailed description
Evidence from the laboratory over the past 10-15 years has demonstrated that heat stress to the ear is otoprotectant against a variety of insults. The strongest evidence supports heat-shock protein 70 (Hsp70) as a key facilitator in this protection. Hsp70 is well established as a cell stabilizer, especially for cells undergoing significant stress. Hsp70 has been shown to protect against cisplatin-induced ototoxicity. Induction of Hsp70 may be accomplished pharmacologically, by whole-body heat stress, or by local heat stress. A form of local heat-stress is already employed in the common clinical setting of the warm caloric. This vestibular test has been in place since the early 20th century with a variety of studies evaluating the patient vestibular response to a variety of times and temperatures. Current clinical practice recommends either water or air calorics of 45°C or 50°C (respectively) at 45-60 seconds.
Several studies have described administering prolonged caloric stimulation to individual subjects without ill effect. Patients are able to tolerate stimulation up to 60 minutes without intolerable nystagmus or vertiginous symptoms or significant injury. Thus, it is feasible to provide warm stimulus to the ear for the recommended time of 30 minutes at the recommended temperature of 50°C (air) without significant risk to the patient.
The purpose of this study is to evaluate the impact of heat stress to the inner ear as an otoprotectant intervention against cisplatin-induced hearing loss. Patients that meet inclusion criteria will be offered audiometric evaluation before each cisplatin treatment and at 1, 3, 6, and 12 months following their chemotherapy. Patients will undergo their heat-stress 5-7 hours prior to their cisplatin treatment. Patients will serve as their own controls with one ear randomly receiving treatment and the other not. The primary outcome will be audiometric testing. Blood samples will be collected for serum levels of Hsp70 as a secondary outcome. A sample size of 12 achieves 80% power to detect a 0.9 standard deviation difference between ears using a two-sided paired t-test at 0.05 significance level.
- Conditions
- Hearing Loss
- Being tested
- ICS AirCal3
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ICS AirCal3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometric Effect
Audiometric evaluation will serve as the primary measure of outcome.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start3 Nov 2016
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
Why it stopped: Investigator closed study-no accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Judge, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872844
- Sponsor's protocol ID
- 0170-16-FB
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2016
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Heat-Stress as a Mechanism of Hearing Preservation in Adults Treated With Cisplatin: A Pilot Study
- ClinicalTrials.gov ID
- NCT02872844
- Acronym / sponsor ID
- 0170-16-FB
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator closed study-no accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Evidence from the laboratory over the past 10-15 years has demonstrated that heat stress to the ear is otoprotectant against a variety of insults. The strongest evidence supports heat-shock protein 70 (Hsp70) as a key facilitator in this protection. Hsp70 is well established as a cell stabilizer, especially for cells undergoing significant stress. Hsp70 has been shown to protect against cisplatin-induced ototoxicity. Induction of Hsp70 may be accomplished pharmacologically, by whole-body heat stress, or by local heat stress. A form of local heat-stress is already employed in the common clinical setting of the warm caloric. This vestibular test has been in place since the early 20th century with a variety of studies evaluating the patient vestibular response to a variety of times and temperatures. Current clinical practice recommends either water or air calorics of 45°C or 50°C (respectively) at 45-60 seconds.
Several studies have described administering prolonged caloric stimulation to individual subjects without ill effect. Patients are able to tolerate stimulation up to 60 minutes without intolerable nystagmus or vertiginous symptoms or significant injury. Thus, it is feasible to provide warm stimulus to the ear for the recommended time of 30 minutes at the recommended temperature of 50°C (air) without significant risk to the patient.
The purpose of this study is to evaluate the impact of heat stress to the inner ear as an otoprotectant intervention against cisplatin-induced hearing loss. Patients that meet inclusion criteria will be offered audiometric evaluation before each cisplatin treatment and at 1, 3, 6, and 12 months following their chemotherapy. Patients will undergo their heat-stress 5-7 hours prior to their cisplatin treatment. Patients will serve as their own controls with one ear randomly receiving treatment and the other not. The primary outcome will be audiometric testing. Blood samples will be collected for serum levels of Hsp70 as a secondary outcome. A sample size of 12 achieves 80% power to detect a 0.9 standard deviation difference between ears using a two-sided paired t-test at 0.05 significance level.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heat-stress | Experimental | Device: ICS AirCal3Each 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient undergoing total cisplatin in total doses > 100mg/m2.
- Written consent.
- Age > 19 years.
Key exclusion criteria (5 listed)
- Inability to tolerate the intervention
- Exposure to cisplatin treatment without intervention.
- Head and neck carcinoma
- Baseline asymmetric hearing loss.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| ICS AirCal3Each 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. | Device | Heat-stress |
Primary outcome
Audiometric Effect
Time frame: One year
Audiometric evaluation will serve as the primary measure of outcome.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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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.
Paul Judge, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing ICS AirCal3 in people with Hearing Loss, run by University of Nebraska.
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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Audiometric Effect (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2023.