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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during treatment (up to 14 days)
Awards & highlights

Study Summary

This trial is to study the effects of high heat and humidity on people with mucositis.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during treatment (up to 14 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during treatment (up to 14 days) for reporting.

Treatment Details

Study Objectives

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

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.

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,128 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a closed or open trial in terms of new participants?

"Unfortunately, this study is no longer recruiting patients according to the latest information found on clinicaltrials.gov. The original posting date was September 1st, 2022 and it was most recently updated on April 28th, 2022. However, there are 4 other trials that might be of interest and are actively seeking participants."

Answered by AI

Has Airvo been cleared by the FDA for therapeutic use?

"Airvo received a score of 2 because, while there is Phase 2 data supporting safety, there is no efficacy data."

Answered by AI

Who else is applying?

What state do they live in?
New York
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
High Heated Humidity in Stem Cell Transplant
2024. "High Heated Humidity in Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05358262.
~56 spots leftby Sep 2025
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