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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

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ClinicalTrials.gov Identifier: NCT01400620
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Izun Pharma Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Oral Mucositis Drug: IZN-6N4 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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. ]
    Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial


Secondary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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, New York, United States, 10003
NYU Clinical Cancer Center
New York, New York, United States, 10016
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

Responsible Party: Izun Pharma Ltd
ClinicalTrials.gov Identifier: NCT01400620     History of Changes
Other Study ID Numbers: IOM-HNC-201-IL
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

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