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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

A

Access Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Oral Mucositis

Treatments

Drug: amlexanox
Drug: Vehicle rinse

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01083875
AP-C-9U01

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

  1. 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:

  2. 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

  3. with planned fields to involve at least 40% of the oral and oropharyngeal mucosa visible by direct inspection;

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

    2. 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.

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

    4. 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

58 participants in 2 patient groups, including a placebo group

0.5% amlexanox oral rinse
Experimental group
Description:
Patients treated with an oral rinse containing the active 0.5% amlexanox
Treatment:
Drug: amlexanox
Vehicle
Placebo Comparator group
Description:
Patients treated with an oral rinse containing no active
Treatment:
Drug: Vehicle rinse

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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