Clinical trial NCT01083875: Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region
Official title: A Double-blind, Randomized, Vehicle-controlled Phase II Study to Determine the Effects of Concomitant Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Mucositis
Keywords: Radiation
mucositis
head and neck carcinoma
oral rinse
amlexanox
MuGard
Lead sponsor: Access Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Advanced Clinical Research Services, LLC
First posted: 2010-03-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score).

A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.


Eligibility criteria: Inclusion Criteria:

1. Patient is 18 years of age or older;
2. Patient has a histologically documented diagnosis of cancer of the head and neck region;
3. Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and with planned fields to involve at least 50% of the oral mucosa;

This criterion was amended (Amendment 01 dated August 28, 2000) to read as follows:

3. Amended: Patient is at a high risk of developing radiation-induced mucositis. For the purpose of this study, high-risk patients will be defined as:

1. patients about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and
2. with planned fields to involve at least 40% of the oral and oropharyngeal mucosa visible by direct inspection;

   4. Patient has a Karnofsky Performance Scale (KPS) score of 60% or more;

   5. Patient is willing and able to cooperate with the protocol including rinsing of the oral cavity with the investigational or vehicle oral rinse 6 times per day.

   6. The patient or guardian is capable of providing informed consent.

   7. If female, the subject has undergone a urine pregnancy test with negative results, and has agreed to practice effective methods of contraception for the duration of the study.

   Exclusion criteria
   1. Patient has had previous radiation therapy to the oral mucosa;
   2. Patient is about to receive hyperfractionated radiation therapy;
   3. Patient has active oral H. simplex lesions, oral candidiasis, or oral mucositis due to other disease processes;
   4. Patient has uncontrolled infection;
   5. Patient has HIV, Hepatitis B (HBV) (as measured by HBs-Ag) or Hepatitis C (HCV) infection;
   6. Patient has not recovered from oral toxicity attributable to prior treatment;
   7. Patient has abnormal laboratory values that meet the following criteria:

      * Serum creatinine greater than 2 x upper limit of normal
      * Total bilirubin greater than 3 x upper limit of normal;
      * SGOT greater than 3 x upper limit of normal;
      * LDH greater than 3 x upper limit of normal;
   8. Patient has known sensitivities to any of the study preparation ingredients;
   9. Patient has participated in a clinical research study within the last 30 days prior to enrollment;
   10. Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or other reasons.

Primary outcomes:
measure: Evaluation of mucositis using the Oral Mucositis Assessment Score
timeFrame: 7 weeks
Secondary outcomes:
measure: Frequency of treatment-emergent, drug-related Serious Adverse Events
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Infirmary Medical Center
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas Medical School
state: Arkansas
city: Bakersfield
country: United States
facility: Florence Wheeler Cancer Center
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Melbourne
country: United States
facility: ICSL Clinical Studies
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University School of Medicine
state: Michigan
city: Memphis
country: United States
facility: University of Tennessee
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Cancer Center
state: Texas
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Paul Busse, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: