Status:
RECRUITING
High Heated Humidity in Stem Cell Transplant
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Autologous Stem Cell Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 recip...
Eligibility Criteria
Inclusion
- Minimum 18 years of age
- 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.
- 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).
- Performance status of ECOG 0-2
- Are reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures.
Exclusion
- 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.
- 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.
- 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.
- Patients with significant co-morbidities that would prevent compliance of equipment use as determined by the treating physician.
- 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.
Key Trial Info
Start Date :
November 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05358262
Start Date
November 5 2024
End Date
January 1 2026
Last Update
January 30 2025
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2