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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sterile Humidification Device
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Helen Diller Family Comprehensive Center, UCSF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sterile Humidification Device, MyPurMist

Arm Description

Sterile Humidification Device Twice a day, 15 minutes each 12 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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

Full Information

First Posted
August 20, 2013
Last Updated
July 11, 2017
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01930435
Brief Title
Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
humidification feasibility and efficacy
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sterile Humidification Device, MyPurMist
Arm Type
Experimental
Arm Description
Sterile Humidification Device Twice a day, 15 minutes each 12 weeks
Intervention Type
Device
Intervention Name(s)
Sterile Humidification Device
Other Intervention Name(s)
MyPurMist
Intervention Description
This is a personal humidification device. It is hand held and produces sterile warm vapor.
Primary Outcome Measure Information:
Title
Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.
Description
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)]
Secondary Outcome Measure Information:
Title
Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.
Description
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
Title
Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks
Description
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
Title
Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification
Description
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
Title
Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Yom, M.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helen Diller Family Comprehensive Center, UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
sharing on request to principal investigator, case by case basis

Learn more about this trial

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

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