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

Primary Purpose

Oral Mucositis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cobiprostone
Placebo
Standard Care - Chemotherapy
Standard Care - Radiation
Sponsored by
Sucampo Pharma Americas, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cobiprostone 30 mcg four times daily

Placebo 0 mcg four times daily

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Overall mean Area Under the Curve (AUC) of oral mucositis severity over time

Secondary Outcome Measures

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

Full Information

First Posted
August 13, 2015
Last Updated
November 26, 2019
Sponsor
Sucampo Pharma Americas, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02542215
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sucampo Pharma Americas, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cobiprostone 30 mcg four times daily
Arm Type
Experimental
Arm Description
Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy
Arm Title
Placebo 0 mcg four times daily
Arm Type
Placebo Comparator
Arm Description
Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
Intervention Type
Drug
Intervention Name(s)
Cobiprostone
Other Intervention Name(s)
SPI-8811
Intervention Description
Cobiprostone 30 mcg oral spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo comparator
Intervention Description
Matching placebo oral spray
Intervention Type
Drug
Intervention Name(s)
Standard Care - Chemotherapy
Other Intervention Name(s)
Chemotherapy
Intervention Description
Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.
Intervention Type
Radiation
Intervention Name(s)
Standard Care - Radiation
Other Intervention Name(s)
Radiation
Intervention Description
Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.
Primary Outcome Measure Information:
Title
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
Time Frame
50 Gray (Gy), up to 12 weeks
Title
Overall mean Area Under the Curve (AUC) of oral mucositis severity over time
Time Frame
50 Gray (Gy), up to 12 weeks
Secondary Outcome Measure Information:
Title
Time-to-onset of severe [World Health Organization (WHO) grade 3 or 4] oral mucositis following initiation of RT/CT
Time Frame
50 Gray (Gy), up to 12 weeks
Title
Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis
Time Frame
50 Gray (Gy), up to 12 weeks
Title
Weekly Quality of Life assessment [MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN)]
Time Frame
50 Gray (Gy), up to 12 weeks
Title
Mean cumulative radiation dose at time of severe (WHO grade 3 or 4) oral mucositis onset
Time Frame
50 Gray (Gy), up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Investigational Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Investigational Site
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
Facility Name
Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Investigational Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Investigational Site
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Investigational Site
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Investigational Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
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United States
Facility Name
Investigational Site
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
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United States
Facility Name
Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
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United States
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Investigational Site
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Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
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United States
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Investigational Site
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Lakeland
State/Province
Florida
ZIP/Postal Code
33805
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United States
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Investigational Site
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Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
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United States
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Investigational Site
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Naples
State/Province
Florida
ZIP/Postal Code
34102
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United States
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Investigational Site
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Plantation
State/Province
Florida
ZIP/Postal Code
33322
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United States
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Investigational Site
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Stuart
State/Province
Florida
ZIP/Postal Code
34994
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United States
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Investigational Site
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Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
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United States
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Investigational Site
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Boise
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Idaho
ZIP/Postal Code
83706
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United States
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Investigational Site
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Urbana
State/Province
Illinois
ZIP/Postal Code
61801
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United States
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Investigational Site
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Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
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United States
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Investigational Site
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South Bend
State/Province
Indiana
ZIP/Postal Code
46601
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United States
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Investigational Site
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Topeka
State/Province
Kansas
ZIP/Postal Code
66606
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United States
Facility Name
Investigational Site
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
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United States
Facility Name
Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
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Investigational Site
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Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
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United States
Facility Name
Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
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United States
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Investigational Site
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Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
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United States
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Investigational Site
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Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
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United States
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Investigational Site
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Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
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United States
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Investigational Site
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Burlington
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Massachusetts
ZIP/Postal Code
01805
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United States
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Investigational Site
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Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
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United States
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Investigational Site
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Detroit
State/Province
Michigan
ZIP/Postal Code
48201
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United States
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Investigational Site
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East Lansing
State/Province
Michigan
ZIP/Postal Code
48867
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United States
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Investigational Site
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Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
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United States
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Investigational Site
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Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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United States
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Investigational Site
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Billings
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Montana
ZIP/Postal Code
59101
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United States
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Investigational Site
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Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
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United States
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Investigational Site
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Reno
State/Province
Nevada
ZIP/Postal Code
89502
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United States
Facility Name
Investigational Site
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Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
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United States
Facility Name
Investigational Site
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New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
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United States
Facility Name
Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
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United States
Facility Name
Investigational Site
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Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
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United States
Facility Name
Investigational Site
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Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
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United States
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Investigational Site
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Canton
State/Province
Ohio
ZIP/Postal Code
44718
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United States
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Investigational Site
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Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
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United States
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Investigational Site
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Oklahoma City
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Oklahoma
ZIP/Postal Code
73104
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United States
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Investigational Site
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Coos Bay
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Oregon
ZIP/Postal Code
97420
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United States
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Investigational Site
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Corvallis
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Oregon
ZIP/Postal Code
97330
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United States
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Investigational Site
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Portland
State/Province
Oregon
ZIP/Postal Code
97227
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United States
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Investigational Site
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Gettysburg
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Pennsylvania
ZIP/Postal Code
17325
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United States
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Investigational Site
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Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
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Investigational Site
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Natrona Heights
State/Province
Pennsylvania
ZIP/Postal Code
15065
Country
United States
Facility Name
Investigational Site
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Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
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United States
Facility Name
Investigational Site
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Investigational Site
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29577
Country
United States
Facility Name
Investigational Site
City
Cookeville
State/Province
Tennessee
ZIP/Postal Code
38501
Country
United States
Facility Name
Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Investigational Site
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Investigational Site
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Investigational Site
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Investigational Site
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States
Facility Name
Investigational Site
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Investigational Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Investigational Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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