Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Radiation and Chemotherapy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Oral Mucositis

In brief

Treatment for head and neck cancer often involves a combination of chemotherapy and radiation. 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.

Key facts

Study ID

NCT02542215

Run by

Sucampo Pharma Americas, LLC

People needed

47

Starts

2015-06-01

Expected to finish

2016-07-01

Last updated by the study team

2019-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recently-diagnosed (within the last 6 months), histologically-documented, non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality.
• 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.

You may not qualify if…

• Subject has received prior radiation to the head and neck region (+/- chemotherapy).
• 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.

Where it is running

• Investigational Site — Peoria, Arizona, United States
• Investigational Site — Yuma, Arizona, United States
• Investigational Site — Little Rock, Arkansas, United States
• Investigational Site — Duarte, California, United States
• Investigational Site — Fullerton, California, United States
• Investigational Site — Los Angeles, California, United States
• Investigational Site — Montebello, California, United States
• Investigational Site — Oceanside, California, United States
• Investigational Site — Redondo Beach, California, United States
• Investigational Site — San Francisco, California, United States
• Investigational Site — Whittier, California, United States
• Investigational Site — Denver, Colorado, United States
• Investigational Site — Farmington, Connecticut, United States
• Investigational Site — Fort Lauderdale, Florida, United States
• Investigational Site — Fort Myers, Florida, United States
• Investigational Site — Lakeland, Florida, United States
• Investigational Site — Miami Beach, Florida, United States
• Investigational Site — Naples, Florida, United States
• Investigational Site — Plantation, Florida, United States
• Investigational Site — Stuart, Florida, United States
• Investigational Site — Winter Haven, Florida, United States
• Investigational Site — Boise, Idaho, United States
• Investigational Site — Urbana, Illinois, United States
• Investigational Site — Fort Wayne, Indiana, United States
• Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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