High Heated Humidity in Stem Cell Transplant

AHS Cancer Control Alberta

Status and phase: Enrolling; Phase 2

Conditions: Autologous Stem Cell Transplant

Treatments: Other: Standard of Care; Device: Airvo

Study type: Interventional

Funder types: Other

Identifiers

NCT05358262

IIT-0017

Details and patient eligibility

About

The purpose of this study is to find out what effects of high heated humidity has on you and your mucositis.

Full description

This is a open label, case-control randomized, phase II clinical trial comparing the use of High Heated Humidity (H3) delivered using the Airvo 2 device to standard of care in Hematologic cancer recipients of autologous stem cell transplant (including Hodgkin lymphoma, non-Hodgkin lymphoma, and multiple myeloma).

Mucositis and aerodigestive tract complications are common across most types of cytotoxic chemotherapies. These complications are both more frequent and severe in recipients of high dose chemotherapy (HDT) and autologous stem cell transplant (ASCT). By extending the use of H3 to include the HDT/ASCT population, there is the possibility to decrease or minimize the complications associated with the current standard treatment process. Shorter, less complicated hospital stays could results for those whose course would otherwise end up being longer due to complications/set- backs. The length of time to use the device per day is a minimum of 4 hours/day up to approximately 14 days while being an inpatient. Treatment beyond 14 days is exceptional and will be done only in those individuals who continue to have mucositis beyond 14 days. In this case, patients may receive treatment up to 30 days.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Minimum 18 years of age
2. Have given written consent prior to any study-specific procedures or have had an acceptable individual capable of giving consent on the patient's behalf.
3. Have one of non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma and found to require high-dose, melphalan-based chemotherapy and autologous stem cell transplant (ASCT) as part of standard of care treatment (includes patients receiving ASCT also requiring oxygen).
4. Performance status of ECOG 0-2
5. Are reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures.

Exclusion criteria

1. Nasal blockage such as nasal polyps, deviated septum or nasal packing would either not allow the proper flow of heated humidity into the nares or it would be too uncomfortable to tolerate during the intervention.
2. Those with influenza like illness. The intervention is not in itself, an aerosol generating medical device. However, if influenza positive, there could be airborne spread of the virus impacting both staff and other patients.
3. Tracheostomy Tube Patients would require a different type of equipment attachment which is not included in this study. Tracheostomy tubes by-pass the upper airway and therefore the intervention cannot be used for the purpose of assessing mucositis. This intervention is used regularly on tracheostomy patients with good success however in this case, the upper airway is by-passed and therefore there would be no impact on mucositis.
4. Patients with significant co-morbidities that would prevent compliance of equipment use as determined by the treating physician.
5. Patients who have Obstructive Sleep Apnea who use a CPAP machine at night. This population would not be able to use the intervention concurrently with the CPAP device as both utilize the nares.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Intervention using the Airvo device

Experimental group

Description:

Patients randomized to this group will receive the standard of care as well as wear the Airvo (equipment to provide high heated humidity) starting on Day 0 of their transplant for a minimum of 4 hours a day (to be worn in one continuous block of time). The humidity is delivered by nasal cannula that goes into your nose, similar to wearing oxygen. The equipment stands on a pole and plugs into a power outlet. Patients may take off the equipment for short periods of time. Eg to go to the bathroom.

Treatment:

Device: Airvo

Standard of Care

Active Comparator group

Description:

Patients randomized into this group will receive the usual standard of care for mucositis. The standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.

Treatment:

Other: Standard of Care