Head and Neck CancerNCT01930435
Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients
A study testing Sterile Humidification Device in people with Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Sterile Humidification Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Helen Diller Family Comprehensive Center, UCSF
San Francisco, California, 94115
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Sterile Humidification Device
- Keywords
- Quality of Life
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile Humidification DeviceDevice
Also called MyPurMist
This is a personal humidification device. It is hand held and produces sterile warm vapor.
| Study group | Role | What they receive |
|---|---|---|
| Sterile Humidification Device, MyPurMist | Experimental | Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Receives: Device: Sterile Humidification Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.
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.
Measured: Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]
Secondary outcomes (4)
Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.
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.
Measured: over entire 12 weeks duration
Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks
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
Measured: over 12 weeks duration
Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification
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.
Measured: over 12 weeks duration
Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification
Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification, determined based on admission to hospital over active study period
Measured: during 12 weeks duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- humidification feasibility and efficacy
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sue Yom, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930435
- Sponsor's protocol ID
- CC# 13202
- Status last verified
- Jul 2017
- First submitted
- 20 Aug 2013
- Last updated
- 10 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: sharing on request to principal investigator, case by case basis
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01930435
- Acronym / sponsor ID
- CC# 13202
- Conditions
- Head and Neck Cancer
- Keywords
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Posted 12 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- humidification feasibility and efficacy
| Arm | Type | Receives |
|---|---|---|
| Sterile Humidification Device, MyPurMist | Experimental | Device: Sterile Humidification DeviceSterile Humidification Device Twice a day, 15 minutes each 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterile Humidification DeviceAlso: MyPurMistThis is a personal humidification device. It is hand held and produces sterile warm vapor. | Device | Sterile Humidification Device, MyPurMist |
Primary outcome
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.
4 secondary outcomes
Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.
Time frame: over entire 12 weeks duration
Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks
Time frame: over 12 weeks duration
Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification
Time frame: over 12 weeks duration
Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification
Time frame: during 12 weeks duration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. sharing on request to principal investigator, case by case basis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Yom, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile Humidification Device in people with Head and Neck Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.