A Randomized, Double-blind Study to Evaluate the Efficacy of MuGard Mucoadhesive Oral Wound Rinse for the Amelioration of Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
To evaluate the efficacy of MuGard on reducing the symptoms of oral mucositis using an Oral Mucositis Daily Questionnaire (OMDQ)
To evaluate the efficacy of MuGard administered every 3 hours up to six times a day (while awake) over approximately 7 weeks in subjects with head and neck cancers receiving up to a maximum cumulative radiation dose of 72 Gray (Gy) compared to sham control on reducing the symptoms of oral mucositis [area-under-the-curve (AUC) of Oral Mucositis Daily Questionnaire (OMDQ) Mouth and Throat Soreness (MTS) Question 2].
7 weeks
No
William Wisbeck, MD
Principal Investigator
Providence Hospital - Pacific Campus; Flynn Cancer Center
United States: Institutional Review Board
APC-10U1101
NCT01283906
January 2011
November 2012
Name | Location |
---|---|
MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
John Muir Medical Center | Walnut Creek, California 94598 |
Vassar Brothers Medical Center | Poughkeepsie, New York 12601 |
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
John B. Amos Cancer Center | Columbus, Georgia 31904 |
Missouri Valley Cancer Consortium | Omaha, Nebraska 68106 |
Ironwood Cancer and Research Centers | Chandler, Arizona 85224 |
21st Century Oncology TRC Headquarters | Scottsdale, Arizona 85251 |
St. Joseph's Mercy Cancer Center- Hot Springs Radiation Oncology | Hot Springs, Arkansas 71913 |
Enloe Medical Center- Cancer Center | Chico, California 95926 |
Signature Healthcare Brockton Hospital | Brockton, Massachusetts 02302 |
VA Western New York Health System | Buffalo, New York 14215 |
CaroMont Health Comprehensive Cancer Center | Gastonia, North Carolina 28054 |
21st Century Oncology- Carolina Radiation Medicine | Greenville, North Carolina 27834 |
PeaceHealth St. Joseph Cancer Center | Bellingham, Washington 98225 |
Providence Hospital - Pacific Campus; Flynn Cancer Center | Everett, Washington 98201 |
Columbia St. Mary's Hospital | Milwaukee, Wisconsin 53211 |