Trial Outcomes & Findings for Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients (NCT NCT01930435)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]

Results posted on

2017-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Sterile Humidification Device, MyPurMist Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sterile Humidification Device, MyPurMist n=20 Participants Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	62.2 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sterile Humidification Device, MyPurMist n=20 Participants Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device
Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.	4.3 units on a scale Interval 3.4 to 5.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sterile Humidification Device, MyPurMist n=20 Participants Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device
Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.	65 percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Sterile Humidification Device, MyPurMist n=20 Participants Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device
Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks	3 units on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sterile Humidification Device, MyPurMist n=20 Participants Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device
Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification	3 participants

SECONDARY outcome

Timeframe: during 12 weeks duration

Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification, determined based on admission to hospital over active study period

Outcome measures

Outcome measures
Measure	Sterile Humidification Device, MyPurMist n=20 Participants Sterile Humidification Device Twice a day, 15 minutes each 12 weeks Sterile Humidification Device
Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification	5 participants

Adverse Events

Sterile Humidification Device, MyPurMist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sue Yom

UCSF

Phone: 415-353-7175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place