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

NCT01930435 | Completed Results DMC

• 1 other identifier: CC# 13202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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)]

Secondary Outcomes (4)

• Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.

  over entire 12 weeks duration

• Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks

  over 12 weeks duration

• Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification

  over 12 weeks duration

• Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification

  during 12 weeks duration

Study Arms (1)

Sterile Humidification Device, MyPurMist

EXPERIMENTAL

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

Device: Sterile Humidification Device

Interventions

Sterile Humidification Device DEVICE

This is a personal humidification device. It is hand held and produces sterile warm vapor.

Also known as: MyPurMist

Sterile Humidification Device, MyPurMist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Helen Diller Family Comprehensive Center, UCSF

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Sue Yom
• Organization: UCSF

yoms@radonc.ucsf.edu

415-353-7175

Study Officials

• Sue Yom, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: humidification feasibility and efficacy

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 29, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 10, 2017
• Results First Posted: January 12, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)