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

Sucampo

Status and phase: Terminated; Phase 2

Conditions: Oral Mucositis

Treatments: Drug: Standard Care - Chemotherapy; Radiation: Standard Care - Radiation; Drug: Placebo; Drug: Cobiprostone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02542215

SCMP-8811-202

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

47 participants in 2 patient groups, including a placebo group

Cobiprostone 30 mcg four times daily

Experimental group

Description:

Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy

Treatment:

Drug: Cobiprostone

Radiation: Standard Care - Radiation

Drug: Standard Care - Chemotherapy

Placebo 0 mcg four times daily

Placebo Comparator group

Description:

Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy

Treatment:

Radiation: Standard Care - Radiation

Drug: Placebo

Drug: Standard Care - Chemotherapy