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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

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IZN-6N4
Sponsored by
Izun Pharma Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring oral mucositis, chemoradiation, head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF Health Cancer Center
  • University of Miami-Sylvester CCC Clinical Research Services
  • Mount Sinai Beth Israel - Phillips Ambulatory Care Center
  • NYU Clinical Cancer Center
  • Soroka Medical Center
  • Rambam Medical Center
  • Rabin Medical Center - Beilinson Campus
  • Sourasky Medical Center
  • Assuta Medical Center
  • Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active oral rinse

Placebo rinse

Arm Description

Oral rinse containing botanical extracts

Outcomes

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
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

Full Information

First Posted
July 20, 2011
Last Updated
March 12, 2018
Sponsor
Izun Pharma Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01400620
Brief Title
Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Izun Pharma Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
oral mucositis, chemoradiation, head and neck cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active oral rinse
Arm Type
Experimental
Arm Description
Oral rinse containing botanical extracts
Arm Title
Placebo rinse
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IZN-6N4
Intervention Description
Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks
Primary Outcome Measure Information:
Title
Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups
Description
Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UF Health Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami-Sylvester CCC Clinical Research Services
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Mount Sinai Beth Israel - Phillips Ambulatory Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
NYU Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Soroka Medical Center
City
Beer Sheba
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Campus
City
Petach Tikva
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Assuta Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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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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