A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients



Status:Completed
Conditions:Cancer, Dental
Therapuetic Areas:Dental / Maxillofacial Surgery, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/2/2013
Start Date:January 2011
End Date:November 2012

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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


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.


Inclusion Criteria:

Subjects will be included in the study if they:

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:

Subjects will be excluded from participation in the study if they:

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
We found this trial at
18
sites
Concord, California 94520
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1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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Bellingham, Washington 98225
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Brockton, Massachusetts 02302
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Buffalo, New York 14215
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Chandler, Arizona 85224
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Chico, California 95926
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1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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Everett, WA
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Gastonia, North Carolina 28054
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Greenville, North Carolina 27834
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Hot Springs, AR
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Milwaukee, Wisconsin 53211
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Omaha, Nebraska 68106
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Poughkeepsie, New York 12601
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Scottsdale, Arizona 85251
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