N/A
N=20
Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01930435 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score. — 4.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sterile Humidification Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score. |
4.3 | — |
| SECONDARY Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification. |
65 | — |
| SECONDARY Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks |
3 | — |
| SECONDARY Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification |
3 | — |
| SECONDARY Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification |
5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01930435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.