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

NCT ID: NCT01083875

Last Updated: 2010-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29
• Study Completion Date: 2001-06-30

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.

Conditions

Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.5% amlexanox oral rinse

Patients treated with an oral rinse containing the active 0.5% amlexanox

Group Type: EXPERIMENTAL

amlexanox

Intervention Type: DRUG

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

Patients treated with an oral rinse containing no active

Group Type: PLACEBO_COMPARATOR

Vehicle rinse

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

MuGard

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Clinical Research Services, LLC

OTHER

Sponsor Role: collaborator

Access Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Paul Busse, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Mobile Infirmary Medical Center

Mobile, Alabama, United States

University of Arkansas Medical School

Little Rock, Arkansas, United States

Florence Wheeler Cancer Center

Bakersfield, California, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

ICSL Clinical Studies

Melbourne, Florida, United States

Loyola University Medical Center

Maywood, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Wayne State University School of Medicine

Detroit, Michigan, United States

University of Tennessee

Memphis, Tennessee, United States

St. Thomas Hospital

Nashville, Tennessee, United States

Arlington Cancer Center

Arlington, Texas, United States

Corpus Christi Cancer Center

Corpus Christi, Texas, United States

Countries

United States

Other Identifiers

AP-C-9U01

Identifier Type: -

Identifier Source: org_study_id