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

Trial Summary

What is the purpose of this trial?

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.

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.

How does the Airvo treatment differ from other treatments for stem cell transplant patients?

The Airvo treatment is unique because it provides high heated humidity, which can help maintain airway moisture and potentially reduce respiratory complications in stem cell transplant patients. This approach is different from standard air filtration methods like HEPA filters, which focus on reducing airborne contaminants rather than directly affecting airway conditions. ^{1 2 3 4 5}

Research Team

Lisa Lem

Principal Investigator

Cross Cancer Institute, Alberta Health Services

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2004]

2. Czech Republic 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]. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Fungal infections after haematology unit renovation: evidence of clinical, environmental and economical impact. [2008]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

[Bacterial contamination of the indoor air in a transplant unit]. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Protective environment for marrow transplant recipients: a prospective study. [2019]