Phase
Condition
Canker Sores
Mucositis
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subjects will be included in the study if they:
Are willing and able to understand and sign an informed consent form (ICF) for thestudy approved by the Investigator's local or a central Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
Are males or females aged 18 years or older
Have recently-diagnosed, pathologically-confirmed cancer of the head and neck (e.g.,oral cavity, oropharynx, hypopharynx, larynx; nasopharynx, lips, sinuses, salivaryglands, or unknown primary)that will be treated with CRT (with or without inductiontherapy prior to CRT)
Have a plan to receive a continuous course of conventional external beam irradiationdelivered as single daily fractions of 2.0 Gy to 2.2 Gy with a cumulative radiationdose between 50 Gy and 72 Gy with concomitant chemotherapy. Planned radiationtreatment fields must include at least two oral sites (buccal mucosa, floor of mouth,tongue, soft palate) with each site receiving at least 50 Gy
Have Karnofsky performance score (KPS) >= 80% or Eastern Cooperative Oncology Group (ECOG) score of <= 1 (See Appendix B and C for KPS and ECOG scores respectively)
Have the ability to comply with the MuGard product insert
Exclusion
Exclusion Criteria: Subjects will be excluded from participation in the study if they:
Have major surgical procedure or significant traumatic injury within 2 weeks prior tothe initiation of RT or anticipation of need for major surgical procedure during thecourse of the study
Have active infectious disease excluding oral candidiasis
Have presence of oral mucositis
Have chronic immunosuppression
Have use of any investigational agent within 30 days of randomization
Are female subjects who are pregnant or breastfeeding
Have known allergies or intolerance to MuGard Mucoadhesive Oral Wound Rinse, itsingredients, or the ingredients used in the sham control. The ingredients which appearin either formulation are as follows: benzalkonium chloride, benzyl alcohol, carbopol 971P, citric acid, glycerin, polysorbate 60, phosphoric acid, purified Water, sodiumbicarbonate, sodium chloride, sodium saccharin
Have inability to give informed consent or comply with study requirements
Are unwilling to or unable to complete the subject diary
Have any other condition or prior therapy that in the opinion of the Investigatorwould make the subject unsuitable for the study or unable to comply with follow-upvisits
Study Design
Connect with a study center
Ironwood Cancer and Research Centers
Mesa, Arizona 85206
United StatesSite Not Available
21st Century Oncology TRC Headquarters
Scottsdale, Arizona 85251
United StatesSite Not Available
St. Joseph's Mercy Cancer Center- Hot Springs Radiation Oncology
Hot Springs, Arkansas 71913
United StatesSite Not Available
Enloe Medical Center- Cancer Center
Chico, California 95926
United StatesSite Not Available
John Muir Medical Center
Concord, California 94520
United StatesSite Not Available
21st Century Oncology - El Segundo, CA
El Segundo, California 90245
United StatesSite Not Available
21st Century Oncology - Lakewood Ranch, FL
Bradenton, Florida 34202
United StatesSite Not Available
21st Century Oncology - Fort Walton Beach, FL
Fort Walton Beach, Florida 32547
United StatesSite Not Available
MD Anderson Cancer Center Orlando
Orlando, Florida 32806
United StatesSite Not Available
Georgia Health Sciences University - College of Dental Medicine
Augusta, Georgia 30912
United StatesSite Not Available
John B. Amos Cancer Center
Columbus, Georgia 31904
United StatesSite Not Available
Signature Healthcare Brockton Hospital
Brockton, Massachusetts 02302
United StatesSite Not Available
21st Century Oncology - Michigan Institute for Radiation Oncology
Farmington Hills, Michigan 48334
United StatesSite Not Available
Missouri Valley Cancer Consortium
Omaha, Nebraska 68106
United StatesSite Not Available
VA Western New York Health System
Buffalo, New York 14215
United StatesSite Not Available
Vassar Brothers Medical Center
Poughkeepsie, New York 12601
United StatesSite Not Available
CaroMont Health Comprehensive Cancer Center
Gastonia, North Carolina 28054
United StatesSite Not Available
21st Century Oncology- Carolina Radiation Medicine
Greenville, North Carolina 27834
United StatesSite Not Available
Abington Memorial Hospital
Abington, Pennsylvania 19001
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
PeaceHealth St. Joseph Cancer Center
Bellingham, Washington 98225
United StatesSite Not Available
Providence Hospital - Pacific Campus; Flynn Cancer Center
Everett, Washington 98201
United StatesSite Not Available
Columbia St. Mary's Hospital
Milwaukee, Wisconsin 53211
United StatesSite Not Available
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