A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients
Public ClinicalTrials.gov record NCT01283906. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01283906
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2011 (Type not available)
- Primary completion
- Apr 2013 (Actual)
- Completion
- May 2013 (Actual)
- Last update posted
- Sep 12, 2013
2011 – 2013
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer and Research Centers | Mesa | Arizona | 85206 | — |
| 21st Century Oncology TRC Headquarters | Scottsdale | Arizona | 85251 | — |
| St. Joseph's Mercy Cancer Center- Hot Springs Radiation Oncology | Hot Springs | Arkansas | 71913 | — |
| Enloe Medical Center- Cancer Center | Chico | California | 95926 | — |
| John Muir Medical Center | Concord | California | 94520 | — |
| MD Anderson Cancer Center Orlando | Orlando | Florida | 32806 | — |
| John B. Amos Cancer Center | Columbus | Georgia | 31904 | — |
| Signature Healthcare Brockton Hospital | Brockton | Massachusetts | 02302 | — |
| Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | — |
| VA Western New York Health System | Buffalo | New York | 14215 | — |
| Vassar Brothers Medical Center | Poughkeepsie | New York | 12601 | — |
| CaroMont Health Comprehensive Cancer Center | Gastonia | North Carolina | 28054 | — |
| 21st Century Oncology- Carolina Radiation Medicine | Greenville | North Carolina | 27834 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | — |
| PeaceHealth St. Joseph Cancer Center | Bellingham | Washington | 98225 | — |
| Providence Hospital - Pacific Campus; Flynn Cancer Center | Everett | Washington | 98201 | — |
| Columbia St. Mary's Hospital | Milwaukee | Wisconsin | 53211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01283906, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 12, 2013 · Synced Nov 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01283906 live on ClinicalTrials.gov.