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

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.

Study Overview

• Status: Completed
• Conditions: Oral Mucositis
• Intervention / Treatment: Device: MuGard; Device: Control Rinse

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Ironwood Cancer and Research Centers
    • Scottsdale, Arizona, United States, 85251
      • 21st Century Oncology TRC Headquarters
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • St. Joseph's Mercy Cancer Center- Hot Springs Radiation Oncology
  • California
    • Chico, California, United States, 95926
      • Enloe Medical Center- Cancer Center
    • Concord, California, United States, 94520
      • John Muir Medical Center
  • Florida
    • Orlando, Florida, United States, 32806
      • MD Anderson Cancer Center Orlando
  • Georgia
    • Columbus, Georgia, United States, 31904
      • John B. Amos Cancer Center
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Signature Healthcare Brockton Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • Missouri Valley Cancer Consortium
  • New York
    • Buffalo, New York, United States, 14215
      • VA Western New York Health System
    • Poughkeepsie, New York, United States, 12601
      • Vassar Brothers Medical Center
  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • CaroMont Health Comprehensive Cancer Center
    • Greenville, North Carolina, United States, 27834
      • 21st Century Oncology- Carolina Radiation Medicine
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • Washington
    • Bellingham, Washington, United States, 98225
      • PeaceHealth St. Joseph Cancer Center
    • Everett, Washington, United States, 98201
      • Providence Hospital - Pacific Campus; Flynn Cancer Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MuGard; Mucoadhesive Oral Wound Rinse	Device: 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
Sham Comparator: Control Rinse; Aqueous Control Rinse.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of MuGard on reducing the symptoms of oral mucositis using an Oral Mucositis Daily Questionnaire (OMDQ)	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].	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of MuGard on delaying the onset of oral mucositis symptoms and reducing the impact on health and resource outcomes.	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.	Approximately 7 weeks

Collaborators and Investigators

• Sponsor: Access Pharmaceuticals, Inc.
• Investigators: Principal Investigator: William Wisbeck, MD, Providence Hospital - Pacific Campus; Flynn Cancer Center; Principal Investigator: Dimitrios Papadopoulos, MD, Vassar Brothers Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Estimate): September 12, 2013
• Last Update Submitted That Met QC Criteria: September 10, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Chemotherapy; Mucositis; Radiation Therapy; Oral Rinse; Squamous Cell Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis
• Other Study ID Numbers: APC-10U1101