Etiz, D., Erkal, H.S., Serin, M., Kucuk, B., Hepari, A., Elhan, A.H., … Cakmak, A. (2000). Clinical and histopathological evaluation of sucralfate in prevention of oral mucositis induced by radiation therapy in patients with head and neck malignancies. Oral Oncology, 36, 116–120.

Patient were randomized to receive sucralfate or placebo, delivered in an oral suspension with identical appearance, taste, and consistency. Patients received six 1-gram doses daily at regular intervals beginning on day one of radiation therapy (RT) and throughout RT, including weekends.

• The study reported on 44 patients with head and neck cancer; 23 received sucralfate and 21 received placebo.
• Mean age of the sample was 55 years with a range of 34–72 years.
• Patients were receiving RT covering at least one-third of the oral mucosa to a minimum dose of 60 Gy.
• Patients were not receiving chemotherapy.

The study was conducted between December 1996 and December 1997.

This was a prospective, randomized, double-blind, placebo-controlled trial.

• Patients received baseline oral examinations and questionnaires with drug- and oral mucositis-related questions.
• The Vander Schueren et al. scoring system was used to assess for mucositis.
• World Health Organization (WHO) criteria for oral and topical analgesics were used.
• Patients underwent biopsy on the 20th day of RT.

• Compliance in the sucralfate group ranged from 3–6 times per day with a median of 5. Patients in the placebo group had a 4–6 times per day compliance rate with a median of 5 (p = 0.21).
• Mean mucositis scores on the 20th day of RT were 2 in the sucralfate group versus 4 in the placebo group (p = 0.0002).
• Pain and dysphagia were reported less frequently in the sucralfate group, but the difference was not significant.
• Patients in the sucralfate group had decreased altered vascular calibration, altered vascular permeability, and leukocyte emigration.

Sucralfate is low in cost, is easily administered, and had a similar compliance rate.

• The sample size was small.
• Compliance rates raise questions.