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

Last updated: September 10, 2013
Sponsor: Access Pharmaceuticals, Inc.
Overall Status: Completed

Phase

4

Condition

Canker Sores

Mucositis

Treatment

N/A

Clinical Study ID

NCT01283906
APC-10U1101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thestudy 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, salivaryglands, or unknown primary)that will be treated with CRT (with or without inductiontherapy prior to CRT)

  4. Have a plan to receive a continuous course of conventional external beam irradiationdelivered as single daily fractions of 2.0 Gy to 2.2 Gy with a cumulative radiationdose between 50 Gy and 72 Gy with concomitant chemotherapy. Planned radiationtreatment 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

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 tothe initiation of RT or anticipation of need for major surgical procedure during thecourse 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, itsingredients, or the ingredients used in the sham control. The ingredients which appearin either formulation are as follows: benzalkonium chloride, benzyl alcohol, carbopol 971P, citric acid, glycerin, polysorbate 60, phosphoric acid, purified Water, sodiumbicarbonate, 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 Investigatorwould make the subject unsuitable for the study or unable to comply with follow-upvisits

Study Design

Total Participants: 120
Study Start date:
January 01, 2011
Estimated Completion Date:
May 31, 2013

Connect with a study center

  • Ironwood Cancer and Research Centers

    Mesa, Arizona 85206
    United States

    Site Not Available

  • 21st Century Oncology TRC Headquarters

    Scottsdale, Arizona 85251
    United States

    Site Not Available

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

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Enloe Medical Center- Cancer Center

    Chico, California 95926
    United States

    Site Not Available

  • John Muir Medical Center

    Concord, California 94520
    United States

    Site Not Available

  • 21st Century Oncology - El Segundo, CA

    El Segundo, California 90245
    United States

    Site Not Available

  • 21st Century Oncology - Lakewood Ranch, FL

    Bradenton, Florida 34202
    United States

    Site Not Available

  • 21st Century Oncology - Fort Walton Beach, FL

    Fort Walton Beach, Florida 32547
    United States

    Site Not Available

  • MD Anderson Cancer Center Orlando

    Orlando, Florida 32806
    United States

    Site Not Available

  • Georgia Health Sciences University - College of Dental Medicine

    Augusta, Georgia 30912
    United States

    Site Not Available

  • John B. Amos Cancer Center

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Signature Healthcare Brockton Hospital

    Brockton, Massachusetts 02302
    United States

    Site Not Available

  • 21st Century Oncology - Michigan Institute for Radiation Oncology

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Missouri Valley Cancer Consortium

    Omaha, Nebraska 68106
    United States

    Site Not Available

  • VA Western New York Health System

    Buffalo, New York 14215
    United States

    Site Not Available

  • Vassar Brothers Medical Center

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • CaroMont Health Comprehensive Cancer Center

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • 21st Century Oncology- Carolina Radiation Medicine

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Abington Memorial Hospital

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • PeaceHealth St. Joseph Cancer Center

    Bellingham, Washington 98225
    United States

    Site Not Available

  • Providence Hospital - Pacific Campus; Flynn Cancer Center

    Everett, Washington 98201
    United States

    Site Not Available

  • Columbia St. Mary's Hospital

    Milwaukee, Wisconsin 53211
    United States

    Site Not Available

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