A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients
NCT ID: NCT01283906
Last Updated: 2013-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2011-01-31
2013-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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MuGard
Mucoadhesive Oral Wound Rinse
MuGard
Mucoadhesive Oral Wound Rinse. 5 mL oral rinse is used to cover the entire oral cavity every 3 hours (while awake) for up to a maximum of 6 doses per day
Control Rinse
Aqueous Control Rinse.
Control Rinse
Aqueous Control Rinse. 5 mL oral rinse is used to cover the entire oral cavity every 3 hours (while awake) for up to a maximum of 6 doses per day.
Interventions
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MuGard
Mucoadhesive Oral Wound Rinse. 5 mL oral rinse is used to cover the entire oral cavity every 3 hours (while awake) for up to a maximum of 6 doses per day
Control Rinse
Aqueous Control Rinse. 5 mL oral rinse is used to cover the entire oral cavity every 3 hours (while awake) for up to a maximum of 6 doses per day.
Eligibility Criteria
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Inclusion Criteria
1. Are willing and able to understand and sign an informed consent form (ICF) for the study approved by the Investigator's local or a central Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
2. Are males or females aged 18 years or older
3. Have recently-diagnosed, pathologically-confirmed cancer of the head and neck (e.g., oral cavity, oropharynx, hypopharynx, larynx; nasopharynx, lips, sinuses, salivary glands, or unknown primary)that will be treated with CRT (with or without induction therapy prior to CRT)
4. Have a plan to receive a continuous course of conventional external beam irradiation delivered as single daily fractions of 2.0 Gy to 2.2 Gy with a cumulative radiation dose between 50 Gy and 72 Gy with concomitant chemotherapy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) with each site receiving at least 50 Gy
5. 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)
6. Have the ability to comply with the MuGard product insert
Exclusion Criteria
1. Have major surgical procedure or significant traumatic injury within 2 weeks prior to the initiation of RT or anticipation of need for major surgical procedure during the course of the study
2. Have active infectious disease excluding oral candidiasis
3. Have presence of oral mucositis
4. Have chronic immunosuppression
5. Have use of any investigational agent within 30 days of randomization
6. Are female subjects who are pregnant or breastfeeding
7. Have known allergies or intolerance to MuGard Mucoadhesive Oral Wound Rinse, its ingredients, or the ingredients used in the sham control. The ingredients which appear in either formulation are as follows: benzalkonium chloride, benzyl alcohol, carbopol 971P, citric acid, glycerin, polysorbate 60, phosphoric acid, purified Water, sodium bicarbonate, sodium chloride, sodium saccharin
8. Have inability to give informed consent or comply with study requirements
9. Are unwilling to or unable to complete the subject diary
10. Have any other condition or prior therapy that in the opinion of the Investigator would make the subject unsuitable for the study or unable to comply with follow-up visits
18 Years
ALL
No
Sponsors
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Access Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Wisbeck, MD
Role: PRINCIPAL_INVESTIGATOR
Providence Hospital - Pacific Campus; Flynn Cancer Center
Dimitrios Papadopoulos, MD
Role: PRINCIPAL_INVESTIGATOR
Vassar Brothers Medical Center
Locations
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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
Countries
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References
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Allison RR, Ambrad AA, Arshoun Y, Carmel RJ, Ciuba DF, Feldman E, Finkelstein SE, Gandhavadi R, Heron DE, Lane SC, Longo JM, Meakin C, Papadopoulos D, Pruitt DE, Steinbrenner LM, Taylor MA, Wisbeck WM, Yuh GE, Nowotnik DP, Sonis ST. Multi-institutional, randomized, double-blind, placebo-controlled trial to assess the efficacy of a mucoadhesive hydrogel (MuGard) in mitigating oral mucositis symptoms in patients being treated with chemoradiation therapy for cancers of the head and neck. Cancer. 2014 May 1;120(9):1433-40. doi: 10.1002/cncr.28553.
Other Identifiers
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APC-10U1101
Identifier Type: -
Identifier Source: org_study_id