Actively Recruiting
Using Highly Heated Humidification to Minimize Aerodigestive Tract Complications of Autologous Stem Cell Transplant
Led by AHS Cancer Control Alberta · Updated on 2025-01-30
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of high heated humidity on mucositis in patients undergoing autologous stem cell transplant for hematologic cancers such as Hodgkin lymphoma, non-Hodgkin lymphoma, and multiple myeloma. This phase II, open-label, randomized clinical trial compares high heated humidity delivered by the Airvo 2 device to the current standard of care. Mucositis and other aerodigestive tract complications commonly occur during high-dose chemotherapy and stem cell transplant, often leading to longer, more complicated hospital stays. Participants are randomly assigned to one of two groups. One group receives standard care plus high heated humidity therapy using the Airvo device, which delivers warm, humidified air through nasal cannula for at least 4 hours daily starting on the day of transplant, typically for up to 14 days but possibly up to 30 days if mucositis persists. The other group receives standard care alone, which includes supportive therapies like oral hydration or medicated mouthwashes. The Airvo device is connected to a power outlet and worn continuously during treatment periods, with brief breaks allowed. Throughout the study, participants will be monitored for mucositis severity symptoms and assessments during treatment, up to 30 days. Researchers will also track secondary outcomes such as febrile neutropenia, infections acquired in the hospital, length of hospital stay, dietary intake, and changes in patient weight from admission to discharge. The study includes daily assessments while inpatients and aims to understand if heated humidity can reduce mucositis complications during stem cell transplant recovery.
CONDITIONS
Brief Title
High Heated Humidity in Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old
- Provide written consent or have an acceptable representative give consent
- Have non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma requiring high-dose melphalan chemotherapy and autologous stem cell transplant
- Have a performance status of ECOG 0-2
- Be reliable and willing to follow study procedures and be available for the study duration
You will not qualify if you...
- Have nasal blockage such as nasal polyps, deviated septum, or nasal packing preventing proper airflow
- Have influenza or flu-like illness
- Have a tracheostomy tube
- Have significant co-morbidities preventing equipment use
- Use a CPAP machine at night for obstructive sleep apnea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive high heated humidification using the Airvo 2 device or standard of care while undergoing autologous stem cell transplant. The device is used for a minimum of 4 hours per day, typically up to 14 days while inpatient, with treatment extending up to 30 days if mucositis persists.
Daily use of the Airvo device during inpatient stay
Trial Site Locations
Total: 1 location
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
Research Team
L
Lisa Lem
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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