High Heated Humidity for Stem Cell Transplant Patients

Overseen By Lisa Lem

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AHS Cancer Control Alberta

Must be taking: Melphalan

Disqualifiers: Nasal blockage, Influenza, Tracheostomy, Obstructive sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 14-30 days

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how high heated humidity might help people with mucositis, a painful inflammation in the mouth, during a stem cell transplant. Participants will either use a device called Airvo, which delivers warm, moist air through a tube in the nose, or receive standard care like medicated mouthwashes. The goal is to determine if the heated air can ease the discomfort of mucositis. This trial suits individuals with non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma who are undergoing a specific type of chemotherapy and stem cell transplant. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves high-dose chemotherapy, it's best to discuss your current medications with the study team or your doctor.

What prior data suggests that the Airvo device is safe for stem cell transplant patients?

Research shows that the Airvo device, which provides warm, moist air, is generally easy to use. Studies with similar devices suggest they can help keep airways moist and may reduce breathing problems. One study found that patients using high-flow heated humidifiers like Airvo experienced fewer days with worsening symptoms and took longer before their symptoms worsened again.

While these results are encouraging, the Airvo device is still being tested specifically for patients undergoing stem cell transplants. Researchers are still gathering safety information. However, its testing in this setting suggests some confidence in its safety so far. As with any treatment, healthcare professionals will monitor participants during the trial to catch any potential issues early. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using the Airvo device for stem cell transplant patients because it offers a unique way to deliver high heated humidity, which could help reduce mucositis, a common and painful side effect. Unlike the standard care options that involve oral hydration and medicated mouthwashes, the Airvo device delivers humidity directly through the nose using a nasal cannula, similar to how oxygen is given. This method ensures a consistent and targeted delivery of humidity, potentially providing more effective relief. The innovative approach could enhance patient comfort and recovery during the challenging post-transplant period.

What evidence suggests that the Airvo device is effective for mucositis?

Research has shown that warm, humid air might help with mouth and throat sores, common in those undergoing intense treatments like stem cell transplants. In this trial, some participants will receive the standard of care along with the Airvo device, which provides warm, moist air. Patients using devices like Airvo have experienced some relief from these sores. Although more studies are needed to confirm these results, the initial findings are promising. The warm, humid air may soothe the mouth and throat, potentially speeding up healing and providing comfort. ^{1 2 6 7 8}

Who Is on the Research Team?

Lisa Lem

Principal Investigator

Cross Cancer Institute, Alberta Health Services

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can take care of myself and perform daily activities.

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.

I have lymphoma or multiple myeloma and need a specific stem cell transplant.

Exclusion Criteria

I don't have nasal blockages that would make breathing through my nose too difficult or painful.

I have Obstructive Sleep Apnea and use a CPAP machine at night.

Patients with significant co-morbidities that would prevent compliance of equipment use as determined by the treating physician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high heated humidity treatment using the Airvo device for a minimum of 4 hours a day, up to 14 days, with possible extension to 30 days if mucositis persists

14-30 days

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Airvo

Trial Overview

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.

How Is the Trial Designed?

Group I: Intervention using the Airvo device Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Published Research Related to This Trial

The installation of HEPA filters in individual rooms significantly reduced the incidence of fungal infections among autotransplant patients, with no cases of proven or probable mould infections reported after the renovation.

The renovation led to a 66% reduction in voriconazole and a 59% reduction in caspofungin usage, resulting in a 17.4% decrease in antifungal therapy costs, highlighting both clinical and economic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fungal infections after haematology unit renovation: evidence of clinical, environmental and economical impact. Araujo, R., Carneiro, A., Costa-Oliveira, S., et al.[2008]

The study monitored microbial contamination in a hospital setting with 96 hemato-oncological patients, including 63 stem cell transplants, to assess the risk of infectious complications.

Opportunistic Gram-negative bacteria were identified from cultures, highlighting the importance of infection control measures in protecting vulnerable patients undergoing stem cell transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The incidence of gram-negative bacteria in the environment of the Transplant Unit, Department of Hemato-oncology, University Hospital --Olomouc]. Holý, O., Matoušková, I., Raida, L.[2014]

A year-long study of indoor air quality in a Transplant Unit revealed that the highest levels of microbial contamination were found in the staff entry room, with 1170 CFU/m3, while patient isolation units had significantly lower contamination levels (150-250 CFU/m3).

The most common airborne bacteria identified were coagulase-negative staphylococci, which are opportunistic pathogens that could pose infection risks to vulnerable haemato-oncology patients, highlighting the need for stringent infection control measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bacterial contamination of the indoor air in a transplant unit]. Matoušková, I., Holý, O.[2019]

Patients with aplastic anemia or acute leukemia who underwent marrow transplantation in a laminar air flow environment experienced significantly fewer cases of septicemia and major local infections compared to those in the control group.

While survival rates were higher in the laminar air flow group (13 of 17 for aplastic anemia and 6 of 29 for acute leukemia) compared to controls, these differences were not statistically significant, indicating that while laminar air flow may reduce infections, it does not significantly impact overall survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective environment for marrow transplant recipients: a prospective study. Buckner, CD., Clift, RA., Sanders, JE., et al.[2019]

Monitoring during construction on a stem cell transplantation ward showed that HEPA air conditioning effectively kept fungal air contamination low in patient rooms, despite increased contamination in surrounding areas.

Patients undergoing stem cell transplantation in HEPA-conditioned rooms did not experience an increase in aspergillosis infections during construction, demonstrating the efficacy of HEPA filtration in protecting vulnerable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective protection of allogeneic stem cell recipients against Aspergillosis by HEPA air filtration during a period of construction--a prospective survey. Krüger, WH., Zöllner, B., Kaulfers, PM., et al.[2004]

Citations

1.

withpower.com

withpower.com/trial/phase-2-autologous-stem-cell-transplant-8-2022-f129f

High Heated Humidity for Stem Cell Transplant Patients

This trial is testing a machine that provides warm, moist air to help heal mouth and throat sores in cancer patients undergoing intense treatments.

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05358262/high-heated-humidity-in-stem-cell-transplant?id=1024&slug=stem-cell-transplant

High Heated Humidity in Stem Cell Transplant

The purpose of this study is to find out what effects of high heated humidity has on you and your mucositis.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8175695/

The influence of high-efficiency particulate air filtration on ...

The median overall survival from ASCT was 7.52 years for the HEPA group and 5.88 years for the remaining patients (non-HEPA group) (p = 0.370).

4.

trial.medpath.com

trial.medpath.com/clinical-trial/bb33fbbf36d006d6/nct05358262-using-heated-humidification-minimize-aerodigestive-complications-autologous-stem-cell-transplant

High Heated Humidity in Stem Cell Transplant | MedPath

The purpose of this study is to find out what effects of high heated humidity has on you and your mucositis.

5.

mdpi.com

mdpi.com/2076-2607/12/11/2352

Seasonal Characterization of the Aerobiome in ...

Seasonal characterization of the aerobiome in hematopoietic stem cell transplant rooms: potential risk for immunosuppressed patients.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02731872

The Effect of Oxygen Therapy With Airvo High-flow Heated ...

The purpose of our study is to establish whether domiciliary use of the Airvo warm passover humidifier can reduce the number of exacerbations in patients ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4848798/

Current evidence for the effectiveness of heated and ...

The results showed that patients on long-term HFNC therapy had significantly fewer exacerbation days, increased time to first exacerbation, and reduced ...

8.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1209977/full

Comparison of actual performance in humidification among ...

This document addresses the basic safety and essential performance requirements of respiratory high-flow therapy equipment. The absolute ...