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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Sterile Humidification Device, MyPurMist
Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Intervention: Sterile Humidification Device (Device)
Outcomes
Primary Outcomes
Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.
Time Frame: 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.
Secondary Outcomes
- 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)