High Heated Humidity in Stem Cell Transplant

ConditionAutologous Stem Cell Transplant

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorAHS Cancer Control Alberta

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Airvo
Device
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
Other intervention
The standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Intervention using the Airvo deviceExperimental treatment 1 intervention

Group B: Standard of CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame