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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Oral Mucositis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the efficacy of MuGard on reducing the symptoms of oral mucositis using an Oral Mucositis Daily Questionnaire (OMDQ)

Outcome 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].

Outcome Time Frame:

7 weeks

Safety Issue:

No

Principal Investigator

William Wisbeck, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Providence Hospital - Pacific Campus; Flynn Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

APC-10U1101

NCT ID:

NCT01283906

Start Date:

January 2011

Completion Date:

November 2012

Related Keywords:

  • Oral Mucositis
  • Mucositis
  • Head and Neck Cancer
  • Squamous Cell Cancer
  • Chemotherapy
  • Radiation Therapy
  • Oral Rinse
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis

Name

Location

MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
John Muir Medical CenterWalnut Creek, California  94598
Vassar Brothers Medical CenterPoughkeepsie, New York  12601
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
John B. Amos Cancer CenterColumbus, Georgia  31904
Missouri Valley Cancer ConsortiumOmaha, Nebraska  68106
Ironwood Cancer and Research CentersChandler, Arizona  85224
21st Century Oncology TRC HeadquartersScottsdale, Arizona  85251
St. Joseph's Mercy Cancer Center- Hot Springs Radiation OncologyHot Springs, Arkansas  71913
Enloe Medical Center- Cancer CenterChico, California  95926
Signature Healthcare Brockton HospitalBrockton, Massachusetts  02302
VA Western New York Health SystemBuffalo, New York  14215
CaroMont Health Comprehensive Cancer CenterGastonia, North Carolina  28054
21st Century Oncology- Carolina Radiation MedicineGreenville, North Carolina  27834
PeaceHealth St. Joseph Cancer CenterBellingham, Washington  98225
Providence Hospital - Pacific Campus; Flynn Cancer CenterEverett, Washington  98201
Columbia St. Mary's HospitalMilwaukee, Wisconsin  53211