Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients
Completed · Not applicable
Conditions studied: Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT01930435
- Run by
- University of California, San Francisco
- People needed
- 20
- Starts
- 2013-07-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2017-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Helen Diller Family Comprehensive Center, UCSF — San Francisco, California, United States
Full record on ClinicalTrials.gov
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