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

University of California San Francisco (UCSF)

Status

Completed

Conditions

Head and Neck Cancer

Treatments

Device: Sterile Humidification Device

Study type

Interventional

Funder types

Other

Identifiers

NCT01930435

CC# 13202

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.