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.
DOI Link
Intervention Characteristics/Basic Study Process
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.
Sample Characteristics
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The study reported on 44 patients with head and neck cancer; 23 received sucralfate and 21 received placebo.
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Mean age of the sample was 55 years with a range of 34–72 years.
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Patients were receiving RT covering at least one-third of the oral mucosa to a minimum dose of 60 Gy.
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Patients were not receiving chemotherapy.
Setting
The study was conducted between December 1996 and December 1997.
Study Design
This was a prospective, randomized, double-blind, placebo-controlled trial.
Measurement Instruments/Methods
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Patients received baseline oral examinations and questionnaires with drug- and oral mucositis-related questions.
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The Vander Schueren et al. scoring system was used to assess for mucositis.
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World Health Organization (WHO) criteria for oral and topical analgesics were used.
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Patients underwent biopsy on the 20th day of RT.
Results
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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).
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Mean mucositis scores on the 20th day of RT were 2 in the sucralfate group versus 4 in the placebo group (p = 0.0002).
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Pain and dysphagia were reported less frequently in the sucralfate group, but the difference was not significant.
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Patients in the sucralfate group had decreased altered vascular calibration, altered vascular permeability, and leukocyte emigration.
Conclusions
Sucralfate is low in cost, is easily administered, and had a similar compliance rate.
Limitations
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The sample size was small.
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Compliance rates raise questions.