Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sucampo Pharma Americas, LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Radiation and Chemotherapy
