Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2024-11-05
2026-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention using the Airvo device
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.
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
Standard of Care
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.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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).
4. Performance status of ECOG 0-2
5. Are reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures.
Exclusion Criteria
2. 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.
3. 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.
4. Patients with significant co-morbidities that would prevent compliance of equipment use as determined by the treating physician.
5. 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.
18 Years
ALL
No
Sponsors
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AHS Cancer Control Alberta
OTHER
Responsible Party
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Principal Investigators
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Lisa Lem
Role: PRINCIPAL_INVESTIGATOR
Cross Cancer Institute, Alberta Health Services
Locations
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Cross Cancer Institute
Edmonton, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT-0017
Identifier Type: -
Identifier Source: org_study_id
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