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High Heated Humidity for Stem Cell Transplant Patients

Phase 2
Waitlist Available
Led By Lisa Lem
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimum 18 years of age
Performance status of ECOG 0-2
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during treatment (up to 14 days)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a machine that provides warm, moist air to help heal mouth and throat sores in cancer patients undergoing intense treatments. The goal is to reduce pain and speed up recovery for these patients.

Who is the study for?
Adults with non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma who need high-dose chemotherapy and a stem cell transplant. They must be able to consent, follow the study plan, and have an ECOG performance status of 0-2. Not for those with sleep apnea using CPAP machines, nasal blockages, influenza-like illness or tracheostomy tubes.
What is being tested?
The trial is testing the effects of high heated humidity delivered through a device called Airvo on mucositis in patients undergoing stem cell transplants as part of their cancer treatment.
What are the potential side effects?
Potential side effects may include discomfort from the heat and humidity delivery system or irritation in the nose if there's sensitivity due to existing conditions like polyps or deviated septum.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 18 years old.
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I can take care of myself and perform daily activities.
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I have lymphoma or multiple myeloma and need a specific stem cell transplant.
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I have lymphoma or multiple myeloma and need a specific stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Obstructive Sleep Apnea and use a CPAP machine at night.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the comparison will be weight at admission vs weight at discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and the comparison will be weight at admission vs weight at discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Patient weight
Mucositis severity assessment
Mucositis severity symptoms
Secondary study objectives
Febrile Neutropenia
Length of stay to be changed in hospital
Nosocomial infections

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention using the Airvo deviceExperimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for stem cell transplant include conditioning regimens like myeloablative conditioning (MAC) and reduced-intensity conditioning (RIC), which work by eradicating malignant cells and suppressing the immune system to prevent graft rejection. Supportive care measures, such as high heated humidity, help maintain moisture in mucous membranes, reducing inflammation and discomfort. These treatments are vital for ensuring successful engraftment and minimizing complications, thereby improving patient outcomes and quality of life during the recovery process.
Health-Related Quality of Life in leukemia Survivors of Allogeneic Hematopoietic Stem Cell Transplantation Employing the Mexican Reduced-Intensity Conditioning.

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
26,747 Total Patients Enrolled
Lisa LemPrincipal InvestigatorCross Cancer Institute, Alberta Health Services

Media Library

Airvo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05358262 — Phase 2
Stem Cell Transplant Research Study Groups: Intervention using the Airvo device, Standard of Care
Stem Cell Transplant Clinical Trial 2023: Airvo Highlights & Side Effects. Trial Name: NCT05358262 — Phase 2
Airvo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05358262 — Phase 2
~56 spots leftby Sep 2025