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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sterile Humidification Device, MyPurMist | Experimental | Sterile Humidification Device Twice a day, 15 minutes each 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile Humidification Device | Device | This is a personal humidification device. It is hand held and produces sterile warm vapor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)] |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue Yom, M.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Diller Family Comprehensive Center, UCSF | San Francisco | California | 94115 | United States |
sharing on request to principal investigator, case by case basis
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| ID | Title | Description |
|---|---|---|
| FG000 | Sterile Humidification Device, MyPurMist | Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sterile Humidification Device, MyPurMist | Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)] |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sterile Humidification Device, MyPurMist | Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device |
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The primary endpoint was based on results from a prior MDASI validation study in a similar population. However, patients enrolled in this study reported a much higher level of symptoms than was recorded in this MDASI validation study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sue Yom | UCSF | 415-353-7175 | yoms@radonc.ucsf.edu |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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humidification feasibility and efficacy
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|
| 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 | 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. | 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 | during 12 weeks duration |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG000 |
| Sterile Humidification Device, MyPurMist |
Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device |
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| Secondary | 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. | Posted | Number | percentage of participants | over entire 12 weeks duration |
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| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | over 12 weeks duration |
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| Secondary | 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. | Posted | Number | participants | over 12 weeks duration |
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| Secondary | 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 | Posted | Number | participants | during 12 weeks duration |
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| 0 |
| 20 |
| 0 |
| 20 |
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