Clinical trial NCT01400620: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Mucositis
Keywords: oral mucositis
chemoradiation
head and neck cancer
Lead sponsor: Izun Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2011-07-22
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups
timeFrame: 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 outcomes:
measure: Incidence of grade 2-3-4 Oral Mucositis as measured by the WHO scale at increasing increments of cumulative radiation exposure
timeFrame: 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.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami-Sylvester CCC Clinical Research Services
state: Florida
city: New York
country: United States
facility: Mount Sinai Beth Israel - Phillips Ambulatory Care Center
state: New York
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
city: Beer Sheba
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Campus
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References: