Clinical trial · Interventional
Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sterile Humidification Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sterile Humidification Device, MyPurMist
- description
- Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
- interventionNames
- Device: Sterile Humidification Device
Primary outcomes (1)
- measure
- Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.
- timeFrame
- Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available