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Oral MucositisPhase 4MuGardNCT01283906

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

A Phase 4 study testing MuGard in people with Oral Mucositis, run by Access Pharmaceuticals, Inc. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oral Mucositis
What is being tested?
MuGard
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
18 sitesUnited States
Study dates
Jan 2011to May 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • PeaceHealth St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Signature Healthcare Brockton Hospital

    Brockton, Massachusetts, 02302

  • VA Western New York Health System

    Buffalo, New York, 14215

  • Enloe Medical Center- Cancer Center

    Chico, California, 95926

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • John Muir Medical Center

    Concord, California, 94520

  • Providence Hospital - Pacific Campus; Flynn Cancer Center

    Everett, Washington, 98201

  • CaroMont Health Comprehensive Cancer Center

    Gastonia, North Carolina, 28054

  • 21st Century Oncology- Carolina Radiation Medicine

    Greenville, North Carolina, 27834

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

    Hot Springs, Arkansas, 71913

  • Ironwood Cancer and Research Centers

    Mesa, Arizona, 85206

  • Columbia St. Mary's Hospital

    Milwaukee, Wisconsin, 53211

  • Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

  • 21st Century Oncology TRC Headquarters

    Scottsdale, Arizona, 85251

Other trials in United States

About this study

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

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.

Conditions
Oral Mucositis
Being tested
MuGard, Control Rinse
Keywords
Mucositis, Head and Neck Cancer, Squamous Cell Cancer, Chemotherapy, Radiation Therapy, Oral Rinse
Medical subject headings
Stomatitis, Mucositis, Head and Neck Neoplasms, Neoplasms, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MuGardDevice

    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

  • Control RinseDevice

    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.

Study groups in NCT01283906
Study groupRoleWhat they receive
MuGardExperimentalMucoadhesive Oral Wound Rinse
Receives: Device: MuGard
Control RinseSham comparatorAqueous Control Rinse.
Receives: Device: Control Rinse

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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].

    Measured: 7 weeks

Secondary outcomes (1)

  1. 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.

    Measured: Approximately 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionApr 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01283906
Sponsor's protocol ID
APC-10U1101
Acronym
MuGard
Status last verified
Sep 2013
First submitted
25 Jan 2011
Last updated
12 Sep 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24877167

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MuGard in people with Oral Mucositis, run by Access Pharmaceuticals, Inc. at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of MuGard on reducing the symptoms of oral mucositis using an Oral Mucositis Daily Questionnaire (OMDQ) (time frame: 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01283906, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2013.

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