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

NCT01930435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-10

Study results available
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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

Interventions

DEVICE

Sterile Humidification Device

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

Sponsors & Collaborators

Principal Investigators

  • Sue Yom, M.D. · University of California, San Francisco

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01930435 on ClinicalTrials.gov