NCT05358262

High Heated Humidity in Stem Cell Transplant

Using Highly Heated Humidification to Minimize Aerodigestive Tract Complications of Autologous Stem Cell Transplant

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Autologous Stem Cell Transplant

Interventions

Type	Name	Description
DEVICE	Airvo	Fisher \& Paykel's AIRVO 2 is a humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of interfaces including nasal cannula. Flow can be delivered from 2 to 60 LPM
OTHER	Standard of Care	The standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.

Timeline

• Start date: 2024-11-05
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2022-05-03
• Last updated: 2025-01-30

Locations

1 site across 1 country: Canada