Clinical trial NCT01930435: 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
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Quality of Life
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: humidification feasibility and efficacy
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.
timeFrame: Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]
Secondary outcomes:
measure: Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.
timeFrame: over entire 12 weeks duration
measure: Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks
timeFrame: over 12 weeks duration
measure: Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification
timeFrame: over 12 weeks duration
measure: Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification
timeFrame: during 12 weeks duration
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Helen Diller Family Comprehensive Center, UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sue Yom, M.D.
role: PRINCIPAL_INVESTIGATOR
References: