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

NCT01283906 | Completed Phase 4

• 1 other identifier: APC-10U1101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 18

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.

Conditions

Oral Mucositis

Keywords

Mucositis; Head and Neck Cancer; Squamous Cell Cancer; Chemotherapy; Radiation Therapy; Oral Rinse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

MuGard

EXPERIMENTAL

Mucoadhesive Oral Wound Rinse

Device: MuGard

Control Rinse

SHAM COMPARATOR

Aqueous Control Rinse.

Device: Control Rinse

Interventions

MuGard DEVICE

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

MuGard

Control Rinse DEVICE

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.

Control Rinse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Access Pharmaceuticals, Inc.: lead

Study Sites (18)

Ironwood Cancer and Research Centers

Mesa, Arizona, 85206, United States

Location

21st Century Oncology TRC Headquarters

Scottsdale, Arizona, 85251, United States

Location

St. Joseph's Mercy Cancer Center- Hot Springs Radiation Oncology

Hot Springs, Arkansas, 71913, United States

Location

Enloe Medical Center- Cancer Center

Chico, California, 95926, United States

Location

John Muir Medical Center

Concord, California, 94520, United States

Location

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

John B. Amos Cancer Center

Columbus, Georgia, 31904, United States

Location

Signature Healthcare Brockton Hospital

Brockton, Massachusetts, 02302, United States

Location

Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

VA Western New York Health System

Buffalo, New York, 14215, United States

Location

Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States

Location

CaroMont Health Comprehensive Cancer Center

Gastonia, North Carolina, 28054, United States

Location

21st Century Oncology- Carolina Radiation Medicine

Greenville, North Carolina, 27834, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

PeaceHealth St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Providence Hospital - Pacific Campus; Flynn Cancer Center

Everett, Washington, 98201, United States

Location

Columbia St. Mary's Hospital

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (1)

• 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.

  PMID: 24877167 DERIVED

MeSH Terms

Conditions

Stomatitis; Mucositis; Head and Neck Neoplasms; Neoplasms, Squamous Cell

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Neoplasms by Site; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• William Wisbeck, MD

  Providence Hospital - Pacific Campus; Flynn Cancer Center

  PRINCIPAL INVESTIGATOR

• Dimitrios Papadopoulos, MD

  Vassar Brothers Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

US (18)