Using high heated humidity to help with mucositis in stem cell transplant patients

Using Highly Heated Humidification to Minimize Aerodigestive Tract Complications of Autologous Stem Cell Transplant

This study is testing if using high heated humidity can help stem cell transplant patients with mouth sores feel better and spend less time in the hospital.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AHS Cancer Control Alberta (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT05358262 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of high heated humidity (H3) delivered via the Airvo 2 device on patients undergoing autologous stem cell transplant for hematologic cancers. It is a phase II, open-label, case-control randomized trial comparing H3 to standard care in managing mucositis and related complications. The treatment is administered for a minimum of 4 hours per day during hospitalization, potentially extending up to 30 days for those with prolonged mucositis. The goal is to reduce the severity of complications and shorten hospital stays for patients receiving high-dose chemotherapy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma requiring high-dose chemotherapy and autologous stem cell transplant.

Not a fit: Patients with nasal blockages or those suffering from influenza-like illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce mucositis severity and improve recovery times for patients undergoing stem cell transplants.

How similar studies have performed: While the use of heated humidity in other contexts has shown promise, this specific application in the autologous stem cell transplant population is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Minimum 18 years of age
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:

1. 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.
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.

Where this trial is running

Edmonton, Alberta

• Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Principal investigator: Lisa Lem — Cross Cancer Institute, Alberta Health Services
• Study coordinator: Lisa Lem

Conditions Autologous Stem Cell Transplant; Mucositis