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Phase III Placebo-Controlled Study of the Inhibition of Radiotherapy-Induced Stomatitis with Chlorhexidine Mouthwash or Oral Antibiotics (Tobramycin/Polymixin E/Amphotericin B) in Patients Receiving Radiotherapy to the Oral Cavity

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Supportive care

Closed

18 and over

NCI

NCCTG-909253
MAYO-909253, NCI-P91-0013

Objectives

I.  Determine by a placebo-controlled, randomized study whether a 
chlorhexidine mouthwash or an antibiotic combination (tobramycin/polymixin 
E/amphotericin B) can decrease the frequency, duration, and severity of 
stomatitis in patients receiving radiotherapy to the oral cavity.
II.  Evaluate the toxic effects of these regimens in this patient population.

Entry Criteria

Disease Characteristics:


Patients scheduled to receive radiotherapy to at least
one-third of oral cavity required
  At least 4,500 cGy in 160-220 cGy fractions OR
  At least 3,000 cGy in fractions of at least 300 cGy

No open mouth sores at entry

Entry required prior to fourth dose of radiotherapy

Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No concurrent cytotoxic chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy to oral mucosa

Surgery:
  Not specified

Other:
  No known intolerance to study agents
  No concurrent or planned use of chlorhexidine or other
     prophylactic drugs or mouthwashes (except alkaline saline
     solutions)

Patient Characteristics:


Age:
  18 and over

Performance status:
  Not specified

Life expectancy:
  Not specified

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No pregnant or lactating women

Expected Enrollment

150 patients (50 per arm) will be accrued over 18-27 months.

Outline

Randomized, double-blind study.  Arm III is not blinded.
Arm I:  Radioprotection.  Chlorhexidine.
Arm II:  Control.  Placebo.
Arm III:  Radioprotection.  Tobramycin/Polymixin E/Amphotericin B.

Published Results

Foote RL, Loprinzi CL, Frank AR, et al.: Randomized trial of a chlorhexidine mouthwash for alleviation of radiation-induced mucositis. J Clin Oncol 12 (12): 2630-3, 1994.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Albert Frank, MD, FACR, Protocol chair(Contact information may not be current)
Ph: 402-280-4634

Mayo Clinic Cancer Center

Charles Loprinzi, MD, Protocol chair
Ph: 507-284-8964
Email: cloprinzi@mayo.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.