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

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects With Head and Neck Cancer (HNC)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02542215

Enrollment

Registered

2015-09-04

Start date

2015-06-30

Completion date

2016-07-31

Last updated

2019-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Mucositis

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.

Interventions

DRUGCobiprostone

Cobiprostone 30 mcg oral spray

DRUGPlacebo

Matching placebo oral spray

DRUGStandard Care - Chemotherapy

Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.

RADIATIONStandard Care - Radiation

Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis	50 Gray (Gy), up to 12 weeks
Weekly Quality of Life assessment [MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN)]	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026