Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05358262

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

Led by AHS Cancer Control Alberta · Updated on 2025-01-30

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of high heated humidity on mucositis in patients undergoing autologous stem cell transplant for hematologic cancers such as Hodgkin lymphoma, non-Hodgkin lymphoma, and multiple myeloma. This phase II, open-label, randomized clinical trial compares high heated humidity delivered by the Airvo 2 device to the current standard of care. Mucositis and other aerodigestive tract complications commonly occur during high-dose chemotherapy and stem cell transplant, often leading to longer, more complicated hospital stays. Participants are randomly assigned to one of two groups. One group receives standard care plus high heated humidity therapy using the Airvo device, which delivers warm, humidified air through nasal cannula for at least 4 hours daily starting on the day of transplant, typically for up to 14 days but possibly up to 30 days if mucositis persists. The other group receives standard care alone, which includes supportive therapies like oral hydration or medicated mouthwashes. The Airvo device is connected to a power outlet and worn continuously during treatment periods, with brief breaks allowed. Throughout the study, participants will be monitored for mucositis severity symptoms and assessments during treatment, up to 30 days. Researchers will also track secondary outcomes such as febrile neutropenia, infections acquired in the hospital, length of hospital stay, dietary intake, and changes in patient weight from admission to discharge. The study includes daily assessments while inpatients and aims to understand if heated humidity can reduce mucositis complications during stem cell transplant recovery.

CONDITIONS

Brief Title

High Heated Humidity in Stem Cell Transplant

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be at least 18 years old
  • Provide written consent or have an acceptable representative give consent
  • Have non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma requiring high-dose melphalan chemotherapy and autologous stem cell transplant
  • Have a performance status of ECOG 0-2
  • Be reliable and willing to follow study procedures and be available for the study duration
Not Eligible

You will not qualify if you...

  • Have nasal blockage such as nasal polyps, deviated septum, or nasal packing preventing proper airflow
  • Have influenza or flu-like illness
  • Have a tracheostomy tube
  • Have significant co-morbidities preventing equipment use
  • Use a CPAP machine at night for obstructive sleep apnea

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 30 days

Participants receive high heated humidification using the Airvo 2 device or standard of care while undergoing autologous stem cell transplant. The device is used for a minimum of 4 hours per day, typically up to 14 days while inpatient, with treatment extending up to 30 days if mucositis persists.

Daily use of the Airvo device during inpatient stay

Trial Site Locations

Total: 1 location

1

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

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Research Team

L

Lisa Lem

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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