NCT05358262 High Heated Humidity in Stem Cell Transplant
| NCT ID | NCT05358262 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AHS Cancer Control Alberta |
| Condition | Autologous Stem Cell Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-11-05 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-11-05 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to find out what effects of high heated humidity has on you and your mucositis.
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.
Contact & Investigator
Lisa Lem
PRINCIPAL INVESTIGATOR
Cross Cancer Institute, Alberta Health Services
Frequently Asked Questions
Who can join the NCT05358262 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autologous Stem Cell Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05358262 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05358262 currently recruiting?
Yes, NCT05358262 is actively recruiting participants. Contact the research team at Lisa.Lem@albertahealthservices.ca for enrollment information.
Where is the NCT05358262 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05358262 clinical trial?
NCT05358262 is sponsored by AHS Cancer Control Alberta. The principal investigator is Lisa Lem at Cross Cancer Institute, Alberta Health Services. The trial plans to enroll 90 participants.