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Oral MucositisPhase 2NCT02542215

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

A Phase 2 study testing Cobiprostone in people with Oral Mucositis, run by Sucampo Pharma Americas, LLC at 76 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oral Mucositis
What is being tested?
Cobiprostone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
76 sitesUnited States
Study dates
Jun 2015to Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • Investigational Site

    Ann Arbor, Michigan, 48109

  • Investigational Site

    Ashland, Kentucky, 41101

  • Investigational Site

    Austin, Texas, 78701

  • Investigational Site

    Baltimore, Maryland, 21201

  • Investigational Site

    Baton Rouge, Louisiana, 70809

  • Investigational Site

    Bellingham, Washington, 98225

  • Investigational Site

    Bethesda, Maryland, 20889

  • Investigational Site

    Billings, Montana, 59101

  • Investigational Site

    Birmingham, Alabama, 35294

  • Investigational Site

    Boise, Idaho, 83706

  • Investigational Site

    Burlington, Massachusetts, 01805

  • Investigational Site

    Canton, Ohio, 44718

  • Investigational Site

    Charlotte, North Carolina, 28203

  • Investigational Site

    Charlottesville, Virginia, 22911

  • Investigational Site

    Cookeville, Tennessee, 38501

  • Investigational Site

    Coos Bay, Oregon, 97420

  • Investigational Site

    Corvallis, Oregon, 97330

  • Investigational Site

    Denver, Colorado, 80210

  • Investigational Site

    Detroit, Michigan, 48201

  • Investigational Site

    Duarte, California, 91010

  • Investigational Site

    East Lansing, Michigan, 48867

  • Investigational Site

    Egg Harbor, New Jersey, 08234

  • Investigational Site

    Everett, Washington, 98201

  • Investigational Site

    Farmington, Connecticut, 06030

  • Investigational Site

    Fort Belvoir, Virginia, 22060

  • Investigational Site

    Fort Lauderdale, Florida, 33316

  • Investigational Site

    Fort Myers, Florida, 33908

  • Investigational Site

    Fort Sam Houston, Texas, 78234

  • Investigational Site

    Fort Wayne, Indiana, 46845

  • Investigational Site

    Fullerton, California, 92835

  • Investigational Site

    Galveston, Texas, 77555

  • Investigational Site

    Gastonia, North Carolina, 28054

  • Investigational Site

    Gettysburg, Pennsylvania, 17325

  • Investigational Site

    Greenville, North Carolina, 27834

  • Investigational Site

    Hershey, Pennsylvania, 17033

  • Investigational Site

    Houston, Texas, 77030

  • Investigational Site

    Houston, Texas, 77089

  • Investigational Site

    Lakeland, Florida, 33805

  • Investigational Site

    Little Rock, Arkansas, 72205

  • Investigational Site

    Los Angeles, California, 90048

  • Investigational Site

    Madison, Wisconsin, 53792

  • Investigational Site

    Metairie, Louisiana, 70006

  • Investigational Site

    Miami Beach, Florida, 33140

  • Investigational Site

    Minneapolis, Minnesota, 55417

  • Investigational Site

    Montebello, California, 90640

  • Investigational Site

    Morgantown, West Virginia, 26506

  • Investigational Site

    Myrtle Beach, South Carolina, 29577

  • Investigational Site

    Naples, Florida, 34102

  • Investigational Site

    Natrona Heights, Pennsylvania, 15065

  • Investigational Site

    New Brunswick, New Jersey, 08901

  • Investigational Site

    New Orleans, Louisiana, 70112

  • Investigational Site

    Oceanside, California, 92056

  • Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Investigational Site

    Omaha, Nebraska, 68198

  • Investigational Site

    Pawtucket, Rhode Island, 02860

  • Investigational Site

    Peoria, Arizona, 85381

  • Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • Investigational Site

    Plantation, Florida, 33322

  • Investigational Site

    Portland, Oregon, 97227

  • Investigational Site

    Redondo Beach, California, 90277

  • Investigational Site

    Reno, Nevada, 89502

  • Investigational Site

    San Francisco, California, 94115

  • Investigational Site

    Seattle, Washington, 98101

  • Investigational Site

    Shreveport, Louisiana, 71103

  • Investigational Site

    South Bend, Indiana, 46601

  • Investigational Site

    St Louis, Missouri, 63110

  • Investigational Site

    State College, Pennsylvania, 16801

  • Investigational Site

    Stuart, Florida, 34994

  • Investigational Site

    Sylvania, Ohio, 43560

  • Investigational Site

    Temple, Texas, 76508

  • Investigational Site

    Topeka, Kansas, 66606

  • Investigational Site

    Urbana, Illinois, 61801

  • Investigational Site

    Whittier, California, 90603

  • Investigational Site

    Winter Haven, Florida, 33880

  • Investigational Site

    Yuma, Arizona, 85364

Other trials in United States

About this study

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)

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.

Conditions
Oral Mucositis
Being tested
Cobiprostone, Placebo, Standard Care - Chemotherapy, Standard Care - Radiation
Medical subject headings
Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CobiprostoneDrug

    Also called SPI-8811

    Cobiprostone 30 mcg oral spray

  • PlaceboDrug

    Also called Placebo comparator

    Matching placebo oral spray

  • Standard Care - ChemotherapyDrug

    Also called Chemotherapy

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

  • Standard Care - RadiationRadiation

    Also called Radiation

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

Study groups in NCT02542215
Study groupRoleWhat they receive
Cobiprostone 30 mcg four times dailyExperimentalCobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy
Receives: Drug: Cobiprostone; Drug: Standard Care - Chemotherapy; Radiation: Standard Care - Radiation
Placebo 0 mcg four times dailyPlacebo comparatorMatching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
Receives: Drug: Placebo; Drug: Standard Care - Chemotherapy; Radiation: Standard Care - Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 50 Gray (Gy), up to 12 weeks

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

    Measured: 50 Gray (Gy), up to 12 weeks

Secondary outcomes (4)

  1. Time-to-onset of severe [World Health Organization (WHO) grade 3 or 4] oral mucositis following initiation of RT/CT

    Measured: 50 Gray (Gy), up to 12 weeks

  2. Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis

    Measured: 50 Gray (Gy), up to 12 weeks

  3. Weekly Quality of Life assessment [MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN)]

    Measured: 50 Gray (Gy), up to 12 weeks

  4. Mean cumulative radiation dose at time of severe (WHO grade 3 or 4) oral mucositis onset

    Measured: 50 Gray (Gy), up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02542215
Sponsor's protocol ID
SCMP-8811-202
Status last verified
Aug 2016
First submitted
13 Aug 2015
Last updated
2 Dec 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cobiprostone in people with Oral Mucositis, run by Sucampo Pharma Americas, LLC at 76 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 50 Gray (Gy), up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02542215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.

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