Head and Neck Cancer
Conditions
Keywords
Quality of Life
Brief 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.
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.
Interventions
DEVICESterile Humidification Device
This is a personal humidification device. It is hand held and produces sterile warm vapor.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
humidification feasibility and efficacy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification. | 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. |
| Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks | 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 |
| Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification | 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. |
| Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification | during 12 weeks duration | Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification, determined based on admission to hospital over active study period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sterile Humidification Device, MyPurMist Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Sterile Humidification Device | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Sterile Humidification Device, MyPurMist |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 62.2 years |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sterile Humidification Device, MyPurMist | Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score. | 4.3 units on a scale |
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
Time frame: over 12 weeks duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sterile Humidification Device, MyPurMist | Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks | 3 units on a scale | Standard Deviation 0.75 |
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.
Time frame: over entire 12 weeks duration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sterile Humidification Device, MyPurMist | Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification. | 65 percentage of participants |
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.
Time frame: over 12 weeks duration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sterile Humidification Device, MyPurMist | Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification | 3 participants |
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
Time frame: during 12 weeks duration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sterile Humidification Device, MyPurMist | Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification | 5 participants |