A Phase II Study Monitoring Quality of Life and Correlative Biomarkers of Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy Utilizing a Personalized Sterile Humidification Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.
研究概览
简要总结
This is a single arm study of the use of a personalized sterile humidification device for 12 weeks for head and neck cancer patients undergoing radiation therapy to determine if the usage of this humidification system will result in a decrease in severity in head and neck related quality of life as measured by the MDASI HN subscale following radiation therapy as compared with historical experience. In addition, we are exploring correlative measures using CRP, IL-1, IL-6, and TNF-alpha level measurements as these are directly related to mucositis and presumably related to quality of life as indicated by the patient.
详细描述
The patients complete MDASI at baseline, 6 weeks, and 12 weeks. The MDASI is a validated instrument that measures symptom burden and we measure a subscale (HN) as our primary endpoint. The patients are asked to use a personal humidifier daily and complete a weekly diary showing compliance with the humidifier use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Receiving a dose of radiation therapy greater than or equal to 6000 cGy to one third of the oral cavity.
- •Receiving definitive or post-operative adjuvant radiotherapy.
- •Receiving radiotherapy or chemoradiation.
- •Of age greater than 18 years.
- •Life expectancy greater than 6 months.
- •Able to provide informed consent.
- •Participation of patients on other clinical trial protocols permitted, if not prohibited by trial guidelines.
排除标准
- •Undergoing induction or neoadjuvant chemotherapy prior to radiotherapy.
- •Treatment with amifostine or palifermin (keratinocyte growth factor) during radiotherapy.
- •High risk for poor compliance with radiotherapy, humidification, or follow-up as assessed by the investigator.
研究组 & 干预措施
Sterile Humidification Device, MyPurMist
Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
干预措施: Sterile Humidification Device (Device)
结局指标
主要结局
Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.
时间窗: Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]
The MDASI-HN assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 NRS, with 0 being "not present" and 10 being "as bad as you can imagine." There are 28 items in the MDASI-HN. There are 13 general inventory items, 6 general interference items, and the HN subscale adds 9 additional items assessing mucus in the mouth and throat, difficulty swallowing/chewing, choking/coughing, difficulty with voice/speech, skin pain/burning/rash, constipation, problems with tasting food, mouth/throat sores, and problems with teeth or gums. Scores for the subscales (general, interference, HN) are averaged so that a score is obtained from 0-10 for each subscale. The mean change in quality of life is calculated as the average scores at 6 weeks minus the average of the scores at baseline. Therefore a positive value represents a worsened quality of life and a negative value is an improvement in quality of life.
次要结局
- Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.(over entire 12 weeks duration)
- Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification(during 12 weeks duration)
- Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification(over 12 weeks duration)
- Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks(over 12 weeks duration)