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document
Sulfasalazine decreases acute gastrointestinal complications due to pelvic radiotherapy . BACKGROUND Radiation-induced gastrointestinal toxicity is a significant concern for patients who are treated with this modality for pelvic malignancies . Eicosanoids and free radicals are thought to be among the reasons for this effect . Sulfasalazine is an inhibitor of their synthesis in the mucosa . OBJECTlVE : To determine whether sulfasalazine can reduce the radiation-induced acute gastrointestinal complications . METHODS In this prospective , double-blind study , 31 patients receiving pelvic radiotherapy were randomized to receive two sulfasalazine 500-mg tablets twice daily or placebo , administered orally from the first day of irradiation . Patients were evaluated weekly , and gastrointestinal toxicities were graded according to the Late Effect of Normal Tissue-Subjective Objective Management Analytic ( LENT-SOMA ) toxicity table during pelvic radiotherapy . On the last day of week 5 , the subjects were graded endoscopically , and biopsies taken from the rectum were classified histopathologically . RESULTS Groups did not differ in age , gender , tumor site , or irradiation procedure . During radiotherapy , grade 2 or higher gastrointestinal toxicity occurred in 20 % ( 3/15 ) and 63 % ( 10/16 ) of the sulfasalazine and placebo groups , respectively . This difference was significant ( p = 0.017 ) . No statistically significant differences were found in endoscopic and histopathologic evaluations . CONCLUSIONS Sulfasalazine is effective in decreasing clinically acute gastrointestinal toxicities . Long-term follow-up with the subjects will help to determine the net effect of sulfasalazine on the radiation-induced gastrointestinal injuries .
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Intervention_Pharmacological
Sulfasalazine
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Intervention_Pharmacological
Sulfasalazine
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Intervention_Pharmacological
sulfasalazine
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Intervention_Psychological
sulfasalazine
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Intervention_Pharmacological
500-mg tablets twice daily
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Intervention_Control
placebo
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Outcome_Physical
gastrointestinal toxicities
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Outcome_Physical
Late Effect of Normal Tissue-Subjective Objective Management Analytic ( LENT-SOMA ) toxicity table
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Outcome_Physical
grade 2 or higher gastrointestinal toxicity
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Outcome_Other
difference
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Participant_Condition
pelvic malignancies .
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Participant_Sample-size
31
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Participant_Condition
pelvic radiotherapy
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Participant_Condition
radiation-induced gastrointestinal injuries