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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

This study has been completed.
Sponsor:
Collaborator:
Advanced Clinical Research Services, LLC
Information provided by:
Access Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01083875
First received: March 8, 2010
Last updated: March 16, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Oral Mucositis
Drug: amlexanox
Drug: Vehicle rinse
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Access Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Evaluation of mucositis using the Oral Mucositis Assessment Score [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of treatment-emergent, drug-related Serious Adverse Events [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: February 2000
Study Completion Date: June 2001
Arms Assigned Interventions
Experimental: 0.5% amlexanox oral rinse
Patients treated with an oral rinse containing the active 0.5% amlexanox
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.
Placebo Comparator: Vehicle
Patients treated with an oral rinse containing no active
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.
Other Name: MuGard

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083875

Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
United States, Arkansas
University of Arkansas Medical School
Little Rock, Arkansas, United States, 72205
United States, California
Florence Wheeler Cancer Center
Bakersfield, California, United States, 93301
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
ICSL Clinical Studies
Melbourne, Florida, United States, 32935
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60115
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University School of Medicine
Detroit, Michigan, United States, 48201
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
St. Thomas Hospital
Nashville, Tennessee, United States, 37202
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Corpus Christi Cancer Center
Corpus Christi, Texas, United States, 78412
Sponsors and Collaborators
Access Pharmaceuticals, Inc.
Advanced Clinical Research Services, LLC
Investigators
Principal Investigator: Paul Busse, M.D., Ph.D. Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: David Nowotnik
ClinicalTrials.gov Identifier: NCT01083875     History of Changes
Other Study ID Numbers: AP-C-9U01
Study First Received: March 8, 2010
Last Updated: March 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Access Pharmaceuticals, Inc.:
Radiation
mucositis
head and neck carcinoma
oral rinse
amlexanox
MuGard

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Neoplasms
Neoplasms by Site
Stomatognathic Diseases
Amlexanox
Anti-Allergic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014