A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients
- Conditions
- Oral Mucositis
- Interventions
- Device: MuGardDevice: Control Rinse
- Registration Number
- NCT01283906
- Lead Sponsor
- Access Pharmaceuticals, Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Subjects will be included in the study if they:
- 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)
- 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, salivary glands, or unknown primary)that will be treated with CRT (with or without induction therapy prior to CRT)
- 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
- 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
Subjects will be excluded from participation in the study if they:
- 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
- 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, 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
- 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 Investigator would make the subject unsuitable for the study or unable to comply with follow-up visits
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MuGard MuGard Mucoadhesive Oral Wound Rinse Control Rinse Control Rinse Aqueous Control Rinse.
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of MuGard on reducing the symptoms of oral mucositis using an Oral Mucositis Daily Questionnaire (OMDQ) 7 weeks 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 \[area-under-the-curve (AUC) of Oral Mucositis Daily Questionnaire (OMDQ) Mouth and Throat Soreness (MTS) Question 2\].
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of MuGard on delaying the onset of oral mucositis symptoms and reducing the impact on health and resource outcomes. Approximately 7 weeks To evaluate the efficacy of MuGard administered every 3 hours up to six times a day (while awake) in subjects with head and neck cancers receiving up to a maximum cumulative radiation dose of 72 Gy compared to sham control on delaying the onset of oral mucositis symptoms (OMDQ MTS Question 2) and reducing the impact on health and resource outcomes.
Trial Locations
- Locations (18)
21st Century Oncology TRC Headquarters
🇺🇸Scottsdale, Arizona, United States
St. Joseph's Mercy Cancer Center- Hot Springs Radiation Oncology
🇺🇸Hot Springs, Arkansas, United States
Signature Healthcare Brockton Hospital
🇺🇸Brockton, Massachusetts, 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
Enloe Medical Center- Cancer Center
🇺🇸Chico, California, United States
John B. Amos Cancer Center
🇺🇸Columbus, Georgia, United States
John Muir Medical Center
🇺🇸Concord, California, United States
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
21st Century Oncology- Carolina Radiation Medicine
🇺🇸Greenville, North Carolina, United States
Allegheny General Hospital
🇺🇸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
Ironwood Cancer and Research Centers
🇺🇸Mesa, Arizona, United States
Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States