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The purpose of this study is to find out what effects of high heated humidity has on you and your mucositis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention using the Airvo device | Experimental | 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. |
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| Standard of Care | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 30 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 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Febrile Neutropenia | To minimize febrile neutropenia which is low neutrophil count with fever. | During treatment (up to 30 days) |
| Nosocomial infections | To minimize infections during stay in hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Lem | Contact | 780-432-8580 | Lisa.Lem@albertahealthservices.ca |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Lem | Cross Cancer Institute, Alberta Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Recruiting | Edmonton | Alberta | T6G 1Z2 | Canada |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | The standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes. |
|
| During treatment (up to 30 days) |
| Length of stay to be changed in hospital | To minimize hospital stay when infection decreased | During treatment (up to 30 days) |
| Dietary pattern/intake | Because of the direct effect of mucositis on the ability to eat and drink, dietary intake/pattern and weight is likely to be impacted.The 31-point Oral Mucositis Quality of Life (OMQoL) scale is to be used while patients are receiving H3 treatment to subjectively assess patient's dietary quality of life. | During treatment (up to 30 days) |
| Patient weight | Because of the direct effect of mucositis on the ability to eat and drink, dietary intake/pattern and weight is likely to be impacted. | The comparison will be weight at admission vs weight at discharge (Day 14 or Day 30) |
| D009057 |
| Stomatognathic Diseases |