Trial record 1 of 1 for:    APC-10U1101
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A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Access Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01283906
First received: January 25, 2011
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Oral Mucositis
Device: MuGard
Device: Control Rinse
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Access Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To evaluate the efficacy of MuGard on reducing the symptoms of oral mucositis using an Oral Mucositis Daily Questionnaire (OMDQ) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    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:
  • To evaluate the efficacy of MuGard on delaying the onset of oral mucositis symptoms and reducing the impact on health and resource outcomes. [ Time Frame: Approximately 7 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: January 2011
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283906

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

No publications provided by Access Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Access Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01283906     History of Changes
Other Study ID Numbers: APC-10U1101
Study First Received: January 25, 2011
Last Updated: September 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Access Pharmaceuticals, Inc.:
Mucositis
Head and Neck Cancer
Squamous Cell Cancer
Chemotherapy
Radiation Therapy
Oral Rinse

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 16, 2014