Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | July 2013 |
| End Date: | July 2016 |
| Contact: | Romobia Hutchinson |
| Email: | HutchinsonR@cc.ucsf.edu |
| Phone: | 415-353-4294 |
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.
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.
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.
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