Clinical trial NCT02542215: Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Radiation and Chemotherapy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Oral Mucositis
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 50 Gray (Gy), up to 12 weeks
measure: Overall mean Area Under the Curve (AUC) of oral mucositis severity over time
timeFrame: 50 Gray (Gy), up to 12 weeks
Secondary outcomes:
measure: Time-to-onset of severe [World Health Organization (WHO) grade 3 or 4] oral mucositis following initiation of RT/CT
timeFrame: 50 Gray (Gy), up to 12 weeks
measure: Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis
timeFrame: 50 Gray (Gy), up to 12 weeks
measure: Weekly Quality of Life assessment [MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN)]
timeFrame: 50 Gray (Gy), up to 12 weeks
measure: Mean cumulative radiation dose at time of severe (WHO grade 3 or 4) oral mucositis onset
timeFrame: 50 Gray (Gy), up to 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Peoria
country: United States
facility: Investigational Site
state: Arizona
city: Yuma
country: United States
facility: Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site
state: Arkansas
city: Duarte
country: United States
facility: Investigational Site
state: California
city: Fullerton
country: United States
facility: Investigational Site
state: California
city: Los Angeles
country: United States
facility: Investigational Site
state: California
city: Montebello
country: United States
facility: Investigational Site
state: California
city: Oceanside
country: United States
facility: Investigational Site
state: California
city: Redondo Beach
country: United States
facility: Investigational Site
state: California
city: San Francisco
country: United States
facility: Investigational Site
state: California
city: Whittier
country: United States
facility: Investigational Site
state: California
city: Denver
country: United States
facility: Investigational Site
state: Colorado
city: Farmington
country: United States
facility: Investigational Site
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Investigational Site
state: Florida
city: Lakeland
country: United States
facility: Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: Investigational Site
state: Florida
city: Naples
country: United States
facility: Investigational Site
state: Florida
city: Plantation
country: United States
facility: Investigational Site
state: Florida
city: Stuart
country: United States
facility: Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: Investigational Site
state: Florida
city: Boise
country: United States
facility: Investigational Site
state: Idaho
city: Urbana
country: United States
facility: Investigational Site
state: Illinois
city: Fort Wayne
country: United States
facility: Investigational Site
state: Indiana
city: South Bend
country: United States
facility: Investigational Site
state: Indiana
city: Topeka
country: United States
facility: Investigational Site
state: Kansas
city: Ashland
country: United States
facility: Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Bethesda
country: United States
facility: Investigational Site
state: Maryland
city: Burlington
country: United States
facility: Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Investigational Site
state: Michigan
city: Detroit
country: United States
facility: Investigational Site
state: Michigan
city: East Lansing
country: United States
facility: Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: Investigational Site
state: Missouri
city: Billings
country: United States
facility: Investigational Site
state: Montana
city: Omaha
country: United States
facility: Investigational Site
state: Nebraska
city: Reno
country: United States
facility: Investigational Site
state: Nevada
city: Egg Harbor Township
country: United States
facility: Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Investigational Site
state: New Jersey
city: Charlotte
country: United States
facility: Investigational Site
state: North Carolina
city: Gastonia
country: United States
facility: Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Investigational Site
state: North Carolina
city: Canton
country: United States
facility: Investigational Site
state: Ohio
city: Sylvania
country: United States
facility: Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Coos Bay
country: United States
facility: Investigational Site
state: Oregon
city: Corvallis
country: United States
facility: Investigational Site
state: Oregon
city: Portland
country: United States
facility: Investigational Site
state: Oregon
city: Gettysburg
country: United States
facility: Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: Investigational Site
state: Pennsylvania
city: Natrona Heights
country: United States
facility: Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site
state: Pennsylvania
city: State College
country: United States
facility: Investigational Site
state: Pennsylvania
city: Pawtucket
country: United States
facility: Investigational Site
state: Rhode Island
city: Myrtle Beach
country: United States
facility: Investigational Site
state: South Carolina
city: Cookeville
country: United States
facility: Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Investigational Site
state: Texas
city: Fort Sam Houston
country: United States
facility: Investigational Site
state: Texas
city: Galveston
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Temple
country: United States
facility: Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Investigational Site
state: Virginia
city: Fort Belvoir
country: United States
facility: Investigational Site
state: Virginia
city: Bellingham
country: United States
facility: Investigational Site
state: Washington
city: Everett
country: United States
facility: Investigational Site
state: Washington
city: Seattle
country: United States
facility: Investigational Site
state: Washington
city: Morgantown
country: United States
facility: Investigational Site
state: West Virginia
city: Madison
country: United States
facility: Investigational Site
state: Wisconsin
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: