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

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

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.

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.

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.