Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Radiation and Chemotherapy
NCT ID: NCT02542215
Last Updated: 2019-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
47 participants
INTERVENTIONAL
2015-06-30
2016-07-31
Brief Summary
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One of the unfortunate consequences of standard care for head and neck cancer is the development of painful mouth sores, known as oral mucositis.
This study will evaluate the use of cobiprostone spray to prevent oral mucositis, when given for the duration of radiation and chemotherapy (RT/CT) standard care.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Cobiprostone 30 mcg four times daily
Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy
Cobiprostone
Cobiprostone 30 mcg oral spray
Standard Care - Chemotherapy
Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.
Standard Care - Radiation
Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.
Placebo 0 mcg four times daily
Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
Placebo
Matching placebo oral spray
Standard Care - Chemotherapy
Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.
Standard Care - Radiation
Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.
Interventions
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Cobiprostone
Cobiprostone 30 mcg oral spray
Placebo
Matching placebo oral spray
Standard Care - Chemotherapy
Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.
Standard Care - Radiation
Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical treatment plan calls for a minimum of 50 Gy cumulative radiation dose administered via continuous course of external beam irradiation to the oral cavity and/or oropharynx via intensity-modulated radiation therapy (IMRT) and/or image-guided radiation therapy (IGRT), combined with conventional or weekly/tri-weekly cisplatin or carboplatin chemotherapy regimen.
Exclusion Criteria
* Subject has had any other prior invasive malignancy, unless disease-free for a minimum of 3 years.
* Subject has metastatic disease (M1) Stage IV-C.
* Subject has a presence of mucosal ulceration or oral mucositis at screening or develops this prior to randomization, and/or has unhealed wounds remaining from surgical resection and/or excisional biopsy procedure.
* Subject is using a pre-existing feeding tube for nutritional support at study entry.
18 Years
ALL
No
Sponsors
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Sucampo Pharma Americas, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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Investigational Site
Birmingham, Alabama, United States
Investigational Site
Peoria, Arizona, United States
Investigational Site
Yuma, Arizona, United States
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Little Rock, Arkansas, United States
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Duarte, California, United States
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Fullerton, California, United States
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Los Angeles, California, United States
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Montebello, California, United States
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Oceanside, California, United States
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Redondo Beach, California, United States
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San Francisco, California, United States
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Whittier, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Lakeland, Florida, United States
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Miami Beach, Florida, United States
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Naples, Florida, United States
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Plantation, Florida, United States
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Stuart, Florida, United States
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Winter Haven, Florida, United States
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Boise, Idaho, United States
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Urbana, Illinois, United States
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Fort Wayne, Indiana, United States
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South Bend, Indiana, United States
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Topeka, Kansas, United States
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Ashland, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Burlington, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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East Lansing, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Reno, Nevada, United States
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Egg Harbor, New Jersey, United States
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New Brunswick, New Jersey, United States
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Charlotte, North Carolina, United States
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Gastonia, North Carolina, United States
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Greenville, North Carolina, United States
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Canton, Ohio, United States
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Sylvania, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Coos Bay, Oregon, United States
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Corvallis, Oregon, United States
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Portland, Oregon, United States
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Gettysburg, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Natrona Heights, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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State College, Pennsylvania, United States
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Pawtucket, Rhode Island, United States
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Myrtle Beach, South Carolina, United States
Investigational Site
Cookeville, Tennessee, United States
Investigational Site
Austin, Texas, United States
Investigational Site
Fort Sam Houston, Texas, United States
Investigational Site
Galveston, Texas, United States
Investigational Site
Houston, Texas, United States
Investigational Site
Houston, Texas, United States
Investigational Site
Temple, Texas, United States
Investigational Site
Charlottesville, Virginia, United States
Investigational Site
Fort Belvoir, Virginia, United States
Investigational Site
Bellingham, Washington, United States
Investigational Site
Everett, Washington, United States
Investigational Site
Seattle, Washington, United States
Investigational Site
Morgantown, West Virginia, United States
Investigational Site
Madison, Wisconsin, United States
Countries
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Other Identifiers
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SCMP-8811-202
Identifier Type: -
Identifier Source: org_study_id
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