High Heated Humidity for Stem Cell Transplant Patients
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AHS Cancer Control Alberta
Must be taking: Melphalan
Disqualifiers: Nasal blockage, Influenza, Tracheostomy, Obstructive sleep apnea, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing a machine that provides warm, moist air to help heal mouth and throat sores in cancer patients undergoing intense treatments. The goal is to reduce pain and speed up recovery for these patients.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves high-dose chemotherapy, it's best to discuss your current medications with the study team or your doctor.
How does the Airvo treatment differ from other treatments for stem cell transplant patients?
The Airvo treatment is unique because it provides high heated humidity, which can help maintain airway moisture and potentially reduce respiratory complications in stem cell transplant patients. This approach is different from standard air filtration methods like HEPA filters, which focus on reducing airborne contaminants rather than directly affecting airway conditions.
12345Eligibility Criteria
Adults with non-Hodgkin lymphoma, Hodgkin lymphoma, or multiple myeloma who need high-dose chemotherapy and a stem cell transplant. They must be able to consent, follow the study plan, and have an ECOG performance status of 0-2. Not for those with sleep apnea using CPAP machines, nasal blockages, influenza-like illness or tracheostomy tubes.Inclusion Criteria
I am at least 18 years old.
I can take care of myself and perform daily activities.
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.
+4 more
Exclusion Criteria
I don't have nasal blockages that would make breathing through my nose too difficult or painful.
I have Obstructive Sleep Apnea and use a CPAP machine at night.
Patients with significant co-morbidities that would prevent compliance of equipment use as determined by the treating physician
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive high heated humidity treatment using the Airvo device for a minimum of 4 hours a day, up to 14 days, with possible extension to 30 days if mucositis persists
14-30 days
Inpatient stay
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing the effects of high heated humidity delivered through a device called Airvo on mucositis in patients undergoing stem cell transplants as part of their cancer treatment.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention using the Airvo deviceExperimental Treatment1 Intervention
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.
Group II: Standard of CareActive Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cross Cancer InstituteEdmonton, Canada
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Who Is Running the Clinical Trial?
AHS Cancer Control AlbertaLead Sponsor
References
Effective protection of allogeneic stem cell recipients against Aspergillosis by HEPA air filtration during a period of construction--a prospective survey. [2004]High incidence of aspergillosis on transplant units or hematological wards without HEPA air conditioning during periods of demolishing or construction has been reported by several investigators. Here we report monitoring of fungal air contamination during a period of construction on a stem cell transplantation ward using the gravity air-setting plate (GASP) method. Fungal air contamination in HEPA-conditioned patient rooms was constantly low, independent from construction activity. Outside of the patient rooms at the ward's corridor, the fungal load was significantly higher with some peak values. Outside the transplant unit measures of construction led to a significant increase of fungal spore concentration in air. Transplant activity was not reduced during construction and patients were nursed strictly under HEPA conditions. Patients were monitored prospectively for incidence of infections since 1990 and data of patients grafted during construction (n = 28) were compared to those grafted outside building activity (n = 652). An increase of aspergillosis during construction could be clearly excluded. It can be concluded: Nursing of patients undergoing stem cell transplantation in HEPA-conditioned rooms is an effective protection against acquisition of aspergillus-infection, even under environmental conditions with increased air contamination by conidia. The gravity air-setting plate (GASP) method is not expensive and easy to use and allows reliable and quantitative aerobiological spore monitoring.
[The incidence of gram-negative bacteria in the environment of the Transplant Unit, Department of Hemato-oncology, University Hospital --Olomouc]. [2014]A study entitled "Surveillance of Infectious Complications in Hemato-oncological Patients", was conducted at the Department of Hemato-Oncology, University Hospital Olomouc from 1 July 2010 to 31 August 2011. During the study period, a total of 96 patients were hospitalized at that department and 63 stem cell transplants were performed, 43 autologous and 23 allogeneic. Microbial contamination was monitored in indoor air, on selected surfaces, and in health care providers (right hand smear, left and right nostril swabs and scalp hair smear). Opportunistic Gram-negative bacterial strains were selected from the cultures.
Fungal infections after haematology unit renovation: evidence of clinical, environmental and economical impact. [2008]The Haemato-Oncology Unit, Hospital S. Joao, suffered extensive refurbishing intervention in order to adapt for autotransplant patients. Eight new individual rooms with central HEPA filtration system were built. All patients admitted in the department during 14 months prior to and 14 months after renovation works were enrolled. A total of 403 admissions were considered and a detailed analysis of all patients with fungal infections, air quality and antifungal consumption were evaluated in order to study clinical, environmental and economical impact after unit renovation.
[Bacterial contamination of the indoor air in a transplant unit]. [2019]For one year (August 2010 to July 2011), microbial contamination of the indoor air in the Transplant Unit of the Haemato-Oncology Clinic, Olomouc University Hospital was monitored monthly. Twenty sampling sites were singled out and a total of 240 indoor air samples were collected. An MAS-100 air sampler (Merck, GER) was used, air flow rate of 100 liters per minute, 1 minute. The measured values of indoor air temperature were stable. The relative air humidity ranged from 17% to 68%. The highest average value of microbial air contamination was found in the "staff entry room" (1170 CFU/m3). The lowest microbial air contamination (150-250 CFU/m3) was measured in the patient isolation units. The most frequently isolated bacterial strains were coagulase-negative staphylococci (94.3%), followed by Micrococcus spp. (67%) and Bacillus subtilis (11%). It can be assumed that the -source of these airborne bacterial strains are both patients and medical staff. They are classified as -opportunistic pathogens and as such can cause hospital infections among haemato-oncology patients.
Protective environment for marrow transplant recipients: a prospective study. [2019]Laminar air flow isolation and decontamination procedures were evaluated in a prospective randomized study in patients with aplastic anemia or acute leukemia undergoing marrow transplantation from HLA-matched siblings. Patients transplanted in the laminar air flow group had significantly less septicemia and major local infections than did patients in the control group. Nineteen of 46 laminar air flow patients and six of 44 control patients are alive at present. In patients with aplastic anemia the survival was 13 of 17 in the laminar air flow group compared with four of 17 in the control group. In patients with acute leukemia the survival was six of 29 in the laminar air flow group versus two of 27 in the control group. These differences were not statistically significant. Death in both the laminar air flow and control groups was predominantly due to interstitial pneumonitis or recurrent leukemia, which were unaffected by isolation and decontamination.