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

Phase 2

Completed

• Conditions: Oral Mucositis
• Interventions: Drug: Vehicle rinse; Drug: amlexanox

• Registration Number: NCT01083875
• Lead Sponsor: Access Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02
• Study Completion: 2001-06
• Status Verified: 2010-03
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-09
• Study First Posted: 2010-03-10
• Last Update Submitted: 2010-03-16
• Last Update Posted: 2010-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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:

4. 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

5. 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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle rinse	Patients treated with an oral rinse containing no active
0.5% amlexanox oral rinse	amlexanox	Patients treated with an oral rinse containing the active 0.5% amlexanox

Primary Outcome Measures

Name	Time	Method
Evaluation of mucositis using the Oral Mucositis Assessment Score	7 weeks

Secondary Outcome Measures

Name	Time	Method
Frequency of treatment-emergent, drug-related Serious Adverse Events	7 weeks

Trial Locations

Locations (12)

University of Tennessee; 🇺🇸 Memphis, Tennessee, United States

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Corpus Christi Cancer Center; 🇺🇸 Corpus Christi, Texas, United States

Arlington Cancer Center; 🇺🇸 Arlington, Texas, United States

ICSL Clinical Studies; 🇺🇸 Melbourne, Florida, United States

Wayne State University School of Medicine; 🇺🇸 Detroit, Michigan, United States

St. Thomas Hospital; 🇺🇸 Nashville, Tennessee, United States

University of Arkansas Medical School; 🇺🇸 Little Rock, Arkansas, United States

Mobile Infirmary Medical Center; 🇺🇸 Mobile, Alabama, United States

Florence Wheeler Cancer Center; 🇺🇸 Bakersfield, California, United States