Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients
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Trial Identification
Brief Title: A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients
Official Title: 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
Study ID: NCT01283906
Conditions
Study Description
Brief Summary: This study is a randomized, double-blind, sham-controlled, two-arm study conducted in subjects receiving chemoradiation therapy for the treatment of head and neck cancer to assess the efficacy of MuGard. The study will evaluate the ability of MuGard to reduce the symptoms of oral mucositis. The study includes a treatment period of approximately 7 weeks depending on the subject's prescribed radiation plan. MuGard is a liquid that is classified as a medical device. It is a hydrated polymer system (oral hydrogel) and is intended for the management of oral mucositis/stomatitis. When gently distributed within the mouth, the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa. Subjects undergoing chemotherapy with radiation for the treatment of head and neck cancer are at high risk of developing oral mucositis as an adverse side-effect of cancer treatment. MuGard was previously shown to reduce the incidence and severity of mucositis in head and neck cancer patients undergoing radiation therapy when compared with data from historical control groups. The purpose of this study is to perform a direct comparison of the effectiveness of MuGard with a control group.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer and Research Centers, Mesa, Arizona, United States
21st Century Oncology TRC Headquarters, Scottsdale, Arizona, United States
St. Joseph's Mercy Cancer Center- Hot Springs Radiation Oncology, Hot Springs, Arkansas, United States
Enloe Medical Center- Cancer Center, Chico, California, United States
John Muir Medical Center, Concord, California, United States
MD Anderson Cancer Center Orlando, Orlando, Florida, United States
John B. Amos Cancer Center, Columbus, Georgia, United States
Signature Healthcare Brockton Hospital, Brockton, Massachusetts, United States
Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
VA Western New York Health System, Buffalo, New York, United States
Vassar Brothers Medical Center, Poughkeepsie, New York, United States
CaroMont Health Comprehensive Cancer Center, Gastonia, North Carolina, United States
21st Century Oncology- Carolina Radiation Medicine, Greenville, North Carolina, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
PeaceHealth St. Joseph Cancer Center, Bellingham, Washington, United States
Providence Hospital - Pacific Campus; Flynn Cancer Center, Everett, Washington, United States
Columbia St. Mary's Hospital, Milwaukee, Wisconsin, United States
Contact Details
Name: William Wisbeck, MD
Affiliation: Providence Hospital - Pacific Campus; Flynn Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Dimitrios Papadopoulos, MD
Affiliation: Vassar Brothers Medical Center
Role: PRINCIPAL_INVESTIGATOR
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