Autologous Stem Cell TransplantPhase 2NCT05358262
High Heated Humidity in Stem Cell Transplant
A Phase 2 study testing Airvo in people with Autologous Stem Cell Transplant, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to find out what effects of high heated humidity has on you and your mucositis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autologous Stem Cell Transplant
- What is being tested?
- Airvo
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2024to Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Lisa Lem, 780-432-8580, Lisa.Lem@albertahealthservices.ca
About this study
Official title: Using Highly Heated Humidification to Minimize Aerodigestive Tract Complications of Autologous Stem Cell Transplant
The purpose of this study is to find out what effects of high heated humidity has on you and your mucositis.
Read the 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 recipients of autologous stem cell transplant (including Hodgkin lymphoma, non-Hodgkin lymphoma, and multiple myeloma).
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
- Autologous Stem Cell Transplant
- Being tested
- Airvo, Standard of Care
- Keywords
- Mucositis
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirvoDevice
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 CareOther
The standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention using the Airvo device | Experimental | 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. Receives: Device: Airvo |
| Standard of Care | Active comparator | 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucositis severity symptoms
Mucositis is defined as inflammation of the oral and aerodigestive tract mucosa. Patient subjective measure, such as patient reported discomfort or sensation of inability to clear secretion will be observed using the Oral Mucositis Quality of Life Questionnaire.
Measured: During treatment (up to 30 days)
Mucositis severity assessment
Mucositis is defined as inflammation of the oral and aerodigestive tract mucosa. Patient objective measures, such as increased reddening of the mucosa to ulcerations will be observed using the Oral Assessment Guide.
Measured: During treatment (up to 30 days)
Secondary outcomes (5)
Febrile Neutropenia
To minimize febrile neutropenia which is low neutrophil count with fever.
Measured: During treatment (up to 30 days)
Nosocomial infections
To minimize infections during stay in hospital.
Measured: During treatment (up to 30 days)
Length of stay to be changed in hospital
To minimize hospital stay when infection decreased
Measured: During treatment (up to 30 days)
Dietary pattern/intake
Because of the direct effect of mucositis on the ability to eat and drink, dietary intake/pattern and weight is likely to be impacted.The 31-point Oral Mucositis Quality of Life (OMQoL) scale is to be used while patients are receiving H3 treatment to subjectively assess patient's dietary quality of life.
Measured: During treatment (up to 30 days)
Patient weight
Because of the direct effect of mucositis on the ability to eat and drink, dietary intake/pattern and weight is likely to be impacted.
Measured: The comparison will be weight at admission vs weight at discharge (Day 14 or Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start5 Nov 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Stem Cell TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Lem, Principal investigator, Cross Cancer Institute, Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358262
- Sponsor's protocol ID
- IIT-0017
- Status last verified
- Jan 2025
- First submitted
- 19 Apr 2022
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Highly Heated Humidification to Minimize Aerodigestive Tract Complications of Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT05358262
- Acronym / sponsor ID
- IIT-0017
- Conditions
- Autologous Stem Cell Transplant
- Keywords
- Mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 recipients of autologous stem cell transplant (including Hodgkin lymphoma, non-Hodgkin lymphoma, and multiple myeloma).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention using the Airvo device | Experimental | Device: AirvoPatients 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. |
| Standard of Care | Active comparator | Other: Standard of CarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirvoFisher \& 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 | Device | Intervention using the Airvo device |
| Standard of CareThe standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes. | Other | Standard of Care |
Primary outcome
Mucositis severity symptoms
Time frame: During treatment (up to 30 days)
Mucositis is defined as inflammation of the oral and aerodigestive tract mucosa. Patient subjective measure, such as patient reported discomfort or sensation of inability to clear secretion will be observed using the Oral Mucositis Quality of Life Questionnaire.
Mucositis severity assessment
Time frame: During treatment (up to 30 days)
Mucositis is defined as inflammation of the oral and aerodigestive tract mucosa. Patient objective measures, such as increased reddening of the mucosa to ulcerations will be observed using the Oral Assessment Guide.
5 secondary outcomes
Febrile Neutropenia
Time frame: During treatment (up to 30 days)
Nosocomial infections
Time frame: During treatment (up to 30 days)
Length of stay to be changed in hospital
Time frame: During treatment (up to 30 days)
Dietary pattern/intake
Time frame: During treatment (up to 30 days)
Patient weight
Time frame: The comparison will be weight at admission vs weight at discharge (Day 14 or Day 30)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Lem principal investigator
Cross Cancer Institute, Alberta Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Airvo in people with Autologous Stem Cell Transplant, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Lem (780-432-8580, Lisa.Lem@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucositis severity symptoms (time frame: During treatment (up to 30 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.