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EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00574860
Recruitment Status : Terminated (Additional research)
First Posted : December 17, 2007
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM).

Condition or disease Intervention/treatment Phase
Oral Mucositis Head and Neck Cancer Drug: EN3285 Drug: Placebo Other: Standard of care Phase 3

Detailed Description:
This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Patients With Head and Neck Cancer Receiving Chemoradiotherapy
Study Start Date : December 2007
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: EN3285 (NAC ProGelz)
The EN3285 arm is the product under development
Drug: EN3285
Oral rinse
Placebo Comparator: No active ingredients (placebo)
This will be an oral product that contains no active ingredient
Drug: Placebo
Oral rinse
Standard of Care
This arm will reflect the typical standard of care for the patient
Other: Standard of care
This will be the therapy most commonly used the the institution treating the patient


Outcome Measures

Primary Outcome Measures :
  1. NCI v3 to measure severity of OM [ Time Frame: At 50 Gy ]

Secondary Outcome Measures :
  1. WHO criteria for measuring severity of OM [ Time Frame: At 50 Gy ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Significant Inclusion Criteria:

  • 18 years and older
  • newly diagnosed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT.
  • Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx
  • Chemotherapy: cisplatin
  • Have a WBC ≥3500 per cubic millimeter
  • Have a platelet count ≥100,000 per cubic millimeter
  • Have adequate renal function as determined by the principal investigator prior to enrollment
  • Are willing and able to undergo oral assessments
  • Have a Karnofsky Performance Status score ≥70

Significant Exclusion Criteria:

  • Have OM or other oral conditions at study entry
  • Plan to use Amifostine, Pilocarpine, Cevimeline or Bethanechol
  • Are using a pre-existing feeding tube for nutritional support at study entry
  • Plan to use any drug for the treatment or prevention of OM
  • Have had any prior radiotherapy to the head and neck
  • Have had prior chemotherapy within 6 months preceding enrollment
  • Plan to have concurrent chemotherapy, other than those regimens specified under inclusioncriteria
  • Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug
  • Have medical conditions that require the use of chronic steroid therapy
  • Have the inability to undergo repeat treatments,
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574860


Locations
United States, Kentucky
Commonwealth ENT
Louisville, Kentucky, United States, 40207
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Principal Investigator: Mark Chambers, MD M.D. Anderson Cancer Center
More Information

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00574860     History of Changes
Other Study ID Numbers: EN3285-301
First Posted: December 17, 2007    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013

Keywords provided by Endo Pharmaceuticals:
Oral Mucositis
Chemoradiation therapy
Head and neck cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases