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Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Izun Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01400620
First received: July 20, 2011
Last updated: November 13, 2016
Last verified: November 2016
  Purpose
The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.

Condition Intervention Phase
Oral Mucositis
Drug: IZN-6N4
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2 Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Izun Pharma Ltd:

Primary Outcome Measures:
  • Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups [ Time Frame: Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks. ] [ Designated as safety issue: No ]
    Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial


Secondary Outcome Measures:
  • Incidence of grade 2-3-4 Oral Mucositis as measured by the WHO scale at increasing increments of cumulative radiation exposure [ Time Frame: Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks. ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: March 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active oral rinse
Oral rinse containing botanical extracts
Drug: IZN-6N4
Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks
Placebo Comparator: Placebo rinse Drug: IZN-6N4
Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks

  Eligibility

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

Inclusion Criteria:

  • diagnosis of head and neck cancer
  • planned treatment course to include Cisplatin and radiation therapy, cumulative prescription dose between 50-70 Gy
  • able to eat at least soft solids
  • normal cardiac function
  • able to perform oral rinse

Exclusion Criteria:

  • Induction chemotherapy regimen
  • life threatening allergic reaction to food and/or drugs
  • history of any other primary malignancy diagnosed within the past 5 years
  • prior radiation to the sites to be treated
  • active infections of the oral cavity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400620

Locations
United States, Florida
UF Health Cancer Center
Gainesville, Florida, United States, 32610
University of Miami-Sylvester CCC Clinical Research Services
Miami, Florida, United States, 33136
United States, New York
Mount Sinai Beth Israel - Phillips Ambulatory Care Center
New York City, New York, United States, 10003
NYU Clinical Cancer Center
New York City, New York, United States, 10016
United States, Wisconsin
Medical College of Wisconsin - Cancer Center
Milwaukee, Wisconsin, United States, 53226
Israel
Soroka Medical Center
Beer Sheba, Israel
Rambam Medical Center
Haifa, Israel
Rabin Medical Center - Beilinson Campus
Petach Tikva, Israel
Sourasky Medical Center
Tel Aviv, Israel, 64239
Assuta Medical Center
Tel Aviv, Israel
Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Izun Pharma Ltd
  More Information

Responsible Party: Izun Pharma Ltd
ClinicalTrials.gov Identifier: NCT01400620     History of Changes
Other Study ID Numbers: IOM-HNC-201-IL 
Study First Received: July 20, 2011
Last Updated: November 13, 2016
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Izun Pharma Ltd:
oral mucositis
chemoradiation
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

ClinicalTrials.gov processed this record on December 08, 2016