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. (see Contacts and Locations)
Verified November 2015 by Izun Pharma Ltd
Sponsor:
Information provided by (Responsible Party):
Izun Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01400620
First received: July 20, 2011
Last updated: November 9, 2015
Last verified: November 2015
  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 ]

Estimated Enrollment: 110
Study Start Date: March 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: June 2016 (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
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

Contacts
Contact: Gabriel Nussbaum, MD, PhD +972 -72-245-8950 ext 101 gn@izunpharma.com

Locations
United States, Florida
UF Health Cancer Center Recruiting
Gainesville, Florida, United States, 32610
Contact: Rebecca Beaulieu, MS, CCRC    352-265-0680 ext 87829    SCHMIR@shands.ufl.edu   
Principal Investigator: Robert Amdur, MD         
University of Miami-Sylvester CCC Clinical Research Services Recruiting
Miami, Florida, United States, 33136
Contact: Lilly Sanchez    305-243-0974    Lsanchez@med.miami.edu   
Principal Investigator: Michael Samuels, MD, FACR         
United States, New York
Mount Sinai Beth Israel - Phillips Ambulatory Care Center Recruiting
New York City, New York, United States, 10003
Contact: Rotsen Rocha    212-844-6286    rrocha@CHPNET.ORG   
Contact: Maria Machuca    +1-212-844-6286    MMachuca@chpnet.org   
Principal Investigator: Lawrence B Tena, MD         
NYU Clinical Cancer Center Recruiting
New York City, New York, United States, 10016
Contact: Sadaf Eslami    212-731-6353    Sadaf.Eslami@nyumc.org   
Principal Investigator: Kenneth Hu, MD         
United States, Wisconsin
Medical College of Wisconsin - Cancer Center Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Virginia Katzke, CCRP    414-805-0599    vkatzke@mcw.edu   
Israel
Soroka Medical Center Recruiting
Beer Sheba, Israel
Contact: Nataly Israeli    +972-8-624-4127    Natalyis@clalit.org.il   
Sub-Investigator: Olga Belochitski, MD         
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Guy Froumin    +972 (4) 7771618    g_froumin@rambam.health.gov.il   
Principal Investigator: Rahamim Ben Yoseph, MD         
Rabin Medical Center - Beilinson Campus Recruiting
Petach Tikva, Israel
Contact: Adi Elfasi    +972 3-9377973    adiel22@clalit.org.il   
Principal Investigator: Aharon Popovtzer, MD         
Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Tamar Burg Golani    +972 3 6951824    tamarbu@tlvmc.gov.il   
Principal Investigator: Orit Gutfeld, MD         
Assuta Medical Center Recruiting
Tel Aviv, Israel
Contact: Sigalit Lichtenstein, RN    +972-3-7645282    sigalitl@assuta.co.il   
Principal Investigator: Raphael Pfeffer, MD         
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Rinat Agmon Klein    + 972-3-5307033    Rinat.AgmonKlein@sheba.health.gov.il   
Principal Investigator: Iris Gluck, MD         
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 9, 2015
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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Neoplasms
Neoplasms by Site
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 25, 2016