Local Heat-Stress as a Mechanism of Hearing Preservation

University of Nebraska

Status: Withdrawn

Conditions: Hearing Loss

Treatments: Device: ICS AirCal3

Study type: Interventional

Funder types: Other

Identifiers

NCT02872844

0170-16-FB

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Heat-stress

Experimental group

Description:

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.

Treatment:

Device: ICS AirCal3