High Heated Humidity in Stem Cell Transplant

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autologous Stem Cell Transplant
• Intervention / Treatment: Device: Airvo

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lisa Lem; Phone Number: 780-432-8580; Email: Lisa.Lem@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
      • Contact: Lisa Lem; Phone Number: 780-432-8580; Email: Lisa.Lem@albertahealthservices.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention using the Airvo device; 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.	Device: Airvo; 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
No Intervention: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient weight	Because of the direct effect of mucositis on the ability to eat and drink, a patients weight is likely to be impacted. Weight shifts can occur as part of treatment and fluid shifts.	The comparison will be weight at admission vs weight at discharge
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.	During treatment (up to 14 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.	During treatment (up to 14 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Febrile Neutropenia	To minimize febrile neutropenia which is low neutrophil count with fever.	During treatment (up to 14 days)
Nosocomial infections	To minimize infections during stay in hospital.	During treatment (up to 14 days)
Length of stay to be changed in hospital	To minimize hospital stay when infection decreased	During treatment (up to 14 days)

Collaborators and Investigators

• Sponsor: AHS Cancer Control Alberta
• Investigators: Principal Investigator: Lisa Lem, Cross Cancer Institute, Alberta Health Services

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Mucositis
• Other Study ID Numbers: IIT-0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No