Using Highly Heated Humidification to Minimize Aerodigestive Tract Complications of Autologous Stem Cell Transplant
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Mucositis severity symptoms
研究概览
简要总结
The purpose of this study is to find out what effects of high heated humidity has on you and your mucositis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 18 years of age
- •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.
- •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).
- •Performance status of ECOG 0-2
- •Are reliable and willing to make themselves available for the duration of the study, and are willing to follow study procedures.
排除标准
- •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.
- •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.
- •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.
- •Patients with significant co-morbidities that would prevent compliance of equipment use as determined by the treating physician.
- •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.
结局指标
主要结局
Mucositis severity symptoms
时间窗: During treatment (up to 30 days)
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.
Mucositis severity assessment
时间窗: During treatment (up to 30 days)
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.
次要结局
- Febrile Neutropenia(During treatment (up to 30 days))
- Nosocomial infections(During treatment (up to 30 days))
- Length of stay to be changed in hospital(During treatment (up to 30 days))
- Dietary pattern/intake(During treatment (up to 30 days))
- Patient weight(The comparison will be weight at admission vs weight at discharge (Day 14 or Day 30))