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

Phase 2

Terminated

• Conditions: Oral Mucositis
• Interventions: Drug: Placebo; Drug: Cobiprostone; Drug: Standard Care - Chemotherapy; Radiation: Standard Care - Radiation

• Registration Number: NCT02542215
• Lead Sponsor: Sucampo Pharma Americas, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-04
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Disposition First Submitted: 2019-11-21
• Disposition First Submitted QC: 2019-11-21
• Disposition First Posted: 2019-11-25
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 0 mcg four times daily	Standard Care - Radiation	Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
Cobiprostone 30 mcg four times daily	Standard Care - Chemotherapy	Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy
Placebo 0 mcg four times daily	Placebo	Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
Cobiprostone 30 mcg four times daily	Standard Care - Radiation	Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy
Placebo 0 mcg four times daily	Standard Care - Chemotherapy	Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
Cobiprostone 30 mcg four times daily	Cobiprostone	Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with a diagnosis of severe oral mucositis during the course of receiving up to 50 Gray (Gy) cumulative radiation dose administration with concurrent chemotherapy	50 Gray (Gy), up to 12 weeks
Overall mean Area Under the Curve (AUC) of oral mucositis severity over time	50 Gray (Gy), up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Weekly Quality of Life assessment [MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN)]	50 Gray (Gy), up to 12 weeks
Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis	50 Gray (Gy), up to 12 weeks
Time-to-onset of severe [World Health Organization (WHO) grade 3 or 4] oral mucositis following initiation of RT/CT	50 Gray (Gy), up to 12 weeks
Mean cumulative radiation dose at time of severe (WHO grade 3 or 4) oral mucositis onset	50 Gray (Gy), up to 12 weeks

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Madison, Wisconsin, United States