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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930435
• Other study ID #: CC# 13202
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2013
• Last updated: October 21, 2014
• Start date: July 2013
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• Sterile Humidification Device

Locations

Country	Name	City	State
United States	Helen Diller Family Comprehensive Center, UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in salivary inflammatory biomarkers (CRP, IL-1, IL-6, TNF-alpha) after use of the personalized sterile humidification system.		6 weeks	No
Other	Relationship between the change from baseline in salivary inflammatory biomarkers and the change from baseline in the overall MDASI-HN score after use of the personalized sterile humidification system.		6 weeks	No
Other	Relationship between the change from baseline in salivary inflammatory biomarkers and the change from baseline in the MDASI-HN subscale score after use of the personalized sterile humidification system.		6 weeks	No
Other	Relationship between the change from baseline in salivary inflammatory biomarkers after use of the personalized sterile humidification system and the clinician graded CTCAE-rated mucositis score.		6 weeks	No
Other	Change from baseline in salivary inflammatory biomarkers (CRP, IL-1, IL-6, TNF-alpha) after use of the personalized sterile humidification system.		12 weeks	No
Other	Relationship between the change from baseline in salivary inflammatory biomarkers and the change from baseline in the overall MDASI-HN score after use of the personalized sterile humidification system.		12 weeks	No
Other	Relationship between the change from baseline in salivary inflammatory biomarkers and the change from baseline in the MDASI-HN subscale score after use of the personalized sterile humidification system.		12 weeks	No
Other	Relationship between the change from baseline in salivary inflammatory biomarkers after use of the personalized sterile humidification system and the clinician graded CTCAE-rated mucositis score.		12 weeks	No
Primary	Decreased severity in quality of life as measured by the subscale MDASI-HN score.		6 weeks	No
Secondary	Decreased severity in quality of life as measured by the overall MDASI-HN score.		6 weeks	No
Secondary	Relationship between the MDASI-HN subscale score with the clinician graded CTCAE-rated mucositis score.		12 weeks	No
Secondary	Relationship between the overall MDASI-HN score with the clinician graded CTCAE-rated mucositis score.		6 weeks	No
Secondary	Rate of feeding tube placement in patients who use personalized sterile humidification.		12 weeks	No
Secondary	Rate of hospitalization in patients who use personalized sterile humidification.		12 weeks	No
Secondary	Level of compliance with use of personalized sterile humidification.		Anticipated of 2 years	No
Secondary	Relationship between the overall MDASI-HN score with the clinician graded CTCAE-rated mucositis score.		12 weeks	No