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

Oral Mucositis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01083875
• Other study ID #: AP-C-9U01
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2010
• Last updated: March 16, 2010
• Start date: February 2000
• Est. completion date: June 2001

Study information

• Verified date: March 2010
• Source: Access Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• amlexanox
0.5% amlexanox oral rinse; use 5 ml every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid was be swirled around the mouth then to be swallowed. Repeated daily until completion of radiation therapy: approximately 7-8 weeks.
• Vehicle rinse
use 5 ml of the vehicle rinse every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid is be swirled around the mouth then swallowed.

Locations

Country	Name	City	State
United States	Arlington Cancer Center	Arlington	Texas
United States	Florence Wheeler Cancer Center	Bakersfield	California
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Corpus Christi Cancer Center	Corpus Christi	Texas
United States	Wayne State University School of Medicine	Detroit	Michigan
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	University of Arkansas Medical School	Little Rock	Arkansas
United States	Loyola University Medical Center	Maywood	Illinois
United States	ICSL Clinical Studies	Melbourne	Florida
United States	University of Tennessee	Memphis	Tennessee
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	St. Thomas Hospital	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Access Pharmaceuticals, Inc.	Advanced Clinical Research Services, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of mucositis using the Oral Mucositis Assessment Score		7 weeks	No
Secondary	Frequency of treatment-emergent, drug-related Serious Adverse Events		7 weeks	Yes