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

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
MuGard
Control Rinse
Sponsored by
Access Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring Mucositis, Head and Neck Cancer, Squamous Cell Cancer, Chemotherapy, Radiation Therapy, Oral Rinse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ironwood Cancer and Research Centers
  • 21st Century Oncology TRC Headquarters
  • St. Joseph's Mercy Cancer Center- Hot Springs Radiation Oncology
  • Enloe Medical Center- Cancer Center
  • John Muir Medical Center
  • MD Anderson Cancer Center Orlando
  • John B. Amos Cancer Center
  • Signature Healthcare Brockton Hospital
  • Missouri Valley Cancer Consortium
  • VA Western New York Health System
  • Vassar Brothers Medical Center
  • CaroMont Health Comprehensive Cancer Center
  • 21st Century Oncology- Carolina Radiation Medicine
  • Allegheny General Hospital
  • University of Pittsburgh Medical Center
  • PeaceHealth St. Joseph Cancer Center
  • Providence Hospital - Pacific Campus; Flynn Cancer Center
  • Columbia St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

MuGard

Control Rinse

Arm Description

Mucoadhesive Oral Wound Rinse

Aqueous Control Rinse.

Outcomes

Primary Outcome Measures

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].

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.
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.

Full Information

First Posted
January 25, 2011
Last Updated
September 10, 2013
Sponsor
Access Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01283906
Brief Title
A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients
Acronym
MuGard
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Access Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
Mucositis, Head and Neck Cancer, Squamous Cell Cancer, Chemotherapy, Radiation Therapy, Oral Rinse

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MuGard
Arm Type
Experimental
Arm Description
Mucoadhesive Oral Wound Rinse
Arm Title
Control Rinse
Arm Type
Sham Comparator
Arm Description
Aqueous Control Rinse.
Intervention Type
Device
Intervention Name(s)
MuGard
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Control Rinse
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the efficacy of MuGard on reducing the symptoms of oral mucositis using an Oral Mucositis Daily Questionnaire (OMDQ)
Description
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].
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of MuGard on delaying the onset of oral mucositis symptoms and reducing the impact on health and resource outcomes.
Description
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.
Time Frame
Approximately 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Wisbeck, MD
Organizational Affiliation
Providence Hospital - Pacific Campus; Flynn Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dimitrios Papadopoulos, MD
Organizational Affiliation
Vassar Brothers Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ironwood Cancer and Research Centers
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
21st Century Oncology TRC Headquarters
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
St. Joseph's Mercy Cancer Center- Hot Springs Radiation Oncology
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Enloe Medical Center- Cancer Center
City
Chico
State/Province
California
ZIP/Postal Code
95926
Country
United States
Facility Name
John Muir Medical Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
MD Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
John B. Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Signature Healthcare Brockton Hospital
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
VA Western New York Health System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Vassar Brothers Medical Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
CaroMont Health Comprehensive Cancer Center
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
21st Century Oncology- Carolina Radiation Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
PeaceHealth St. Joseph Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Providence Hospital - Pacific Campus; Flynn Cancer Center
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Columbia St. Mary's Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24877167
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.
Results Reference
derived

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

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