Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients
July 11, 2017 updated by: University of California, San Francisco
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- Helen Diller Family Comprehensive Center, UCSF
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sterile Humidification Device, MyPurMist
Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
|
This is a personal humidification device.
It is hand held and produces sterile warm vapor.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.
Time Frame: over entire 12 weeks duration
|
Compliance was pre-specified in the protocol as self-reported usage of the device at a level equal to or greater than 60% of the formal recommended usage.
This cut-off at 60% represented the median of the distribution of the usage of the device among all patients.
The outcome measure is the percentage of participants who reported using the device at a level equal to or greater than 60% of the total prescribed usage.
|
over entire 12 weeks duration
|
|
Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks
Time Frame: over 12 weeks duration
|
The maximum severity of clinician rating of mucositis observed over 12 weeks, as graded on a scale ranging from 1 (minimal mucositis) to 3 (confluent mucositis) to 5 (death) using the Common Terminology Criteria for Adverse Events v 4.0
|
over 12 weeks duration
|
|
Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification
Time Frame: over 12 weeks duration
|
Feeding Tube Placement in Patients Who Use Personalized Sterile Humidification, as determined by placement of either nasogastric or gastrostomy tube.
This was enumerated as the number of participants who had a feeding tube placed.
|
over 12 weeks duration
|
|
Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification
Time Frame: during 12 weeks duration
|
Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification, determined based on admission to hospital over active study period
|
during 12 weeks duration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sue Yom, M.D., University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
August 20, 2013
First Submitted That Met QC Criteria
August 23, 2013
First Posted (Estimate)
August 29, 2013
Study Record Updates
Last Update Posted (Actual)
August 10, 2017
Last Update Submitted That Met QC Criteria
July 11, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CC# 13202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
sharing on request to principal investigator, case by case basis
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.