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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 currently recruiting participants.
Verified May 2012 by Izun Pharma Ltd
Sponsor:
Information provided by (Responsible Party):
Izun Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01400620
First received: July 20, 2011
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 110
Study Start Date: March 2012
Estimated Primary Completion Date: March 2014 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400620

Contacts
Contact: Haia van Gelderen, BSc, RN +972-2-5860780 haia@izunpharma.com

Locations
Israel
Sourasky Medical Center Recruiting
Tel Aviv, Israel
Principal Investigator: Orit Gutfeld, MD            
Sponsors and Collaborators
Izun Pharma Ltd
  More Information

No publications provided

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: May 23, 2012
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
Stomatitis
Mucositis
Neoplasms by Site
Neoplasms
 Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013