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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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
The standard of care for mucositis at the Cross Cancer institute involves supportive therapies including oral hydration (water or wet sponges) or medicated mouthwashes.
Cross Cancer Institute
Edmonton, Alberta, Canada
RECRUITINGMucositis 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.
Time frame: 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.
Time frame: During treatment (up to 30 days)
Febrile Neutropenia
To minimize febrile neutropenia which is low neutrophil count with fever.
Time frame: During treatment (up to 30 days)
Nosocomial infections
To minimize infections during stay in hospital.
Time frame: During treatment (up to 30 days)
Length of stay to be changed in hospital
To minimize hospital stay when infection decreased
Time frame: 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.
Time frame: During treatment (up to 30 days)
Patient weight
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Because of the direct effect of mucositis on the ability to eat and drink, dietary intake/pattern and weight is likely to be impacted.
Time frame: The comparison will be weight at admission vs weight at discharge (Day 14 or Day 30)