Clinical trial NCT01283906: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Mucositis
Keywords: Mucositis
Head and Neck Cancer
Squamous Cell Cancer
Chemotherapy
Radiation Therapy
Oral Rinse
Lead sponsor: Access Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the efficacy of MuGard on reducing the symptoms of oral mucositis using an Oral Mucositis Daily Questionnaire (OMDQ)
timeFrame: 7 weeks
Secondary outcomes:
measure: To evaluate the efficacy of MuGard on delaying the onset of oral mucositis symptoms and reducing the impact on health and resource outcomes.
timeFrame: Approximately 7 weeks
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Scottsdale
country: United States
facility: 21st Century Oncology TRC Headquarters
state: Arizona
city: Hot Springs
country: United States
facility: St. Joseph's Mercy Cancer Center- Hot Springs Radiation Oncology
state: Arkansas
city: Chico
country: United States
facility: Enloe Medical Center- Cancer Center
state: California
city: Concord
country: United States
facility: John Muir Medical Center
state: California
city: Orlando
country: United States
facility: MD Anderson Cancer Center Orlando
state: Florida
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Brockton
country: United States
facility: Signature Healthcare Brockton Hospital
state: Massachusetts
city: Omaha
country: United States
facility: Missouri Valley Cancer Consortium
state: Nebraska
city: Buffalo
country: United States
facility: VA Western New York Health System
state: New York
city: Poughkeepsie
country: United States
facility: Vassar Brothers Medical Center
state: New York
city: Gastonia
country: United States
facility: CaroMont Health Comprehensive Cancer Center
state: North Carolina
city: Greenville
country: United States
facility: 21st Century Oncology- Carolina Radiation Medicine
state: North Carolina
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Bellingham
country: United States
facility: PeaceHealth St. Joseph Cancer Center
state: Washington
city: Everett
country: United States
facility: Providence Hospital - Pacific Campus; Flynn Cancer Center
state: Washington
city: Milwaukee
country: United States
facility: Columbia St. Mary's Hospital
state: Wisconsin
Study officials:
affiliation: Providence Hospital - Pacific Campus; Flynn Cancer Center
name: William Wisbeck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vassar Brothers Medical Center
name: Dimitrios Papadopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.