Effect of prophylactic sucralfate suspension on stomatitis induced by cancer chemotherapy. A randomized, double-blind cross-over study.
We have studied whether mouth-swishing with sucralfate, a well-known gastric mucosal protective agent, may be used as prophylaxis against chemotherapy-induced stomatitis. Using radioactively labelled sucralfate we found that 20-30% was still bound to the oral mucosal lining 2 1/2 h after mouth-swishing. Forty patients receiving cisplatin and continuous infusion with 5-fluorouracil (5-FU) for 5 days entered a double-blind placebo-controlled cross-over study. Among 23 evaluable patients a significant reduction (p = 0.04) in an objective score of edema, erythema, erosion and ulcerations was seen during treatment with sucralfate. Patient preference favored sucralfate, but this preference failed to reach statistical significance (p = 0.06). Seven patients were inevaluable for reasons not associated with the study treatment. However, ten patients did not complete the study since the swishing procedure aggravated chemotherapy-induced nausea. An equal rate of non-compliance was seen with sucralfate and placebo. To overcome this problem, the oral medication should have a neutral taste, the solution should not be swallowed after the swishing, which should not be started until the nausea had ceased.
Department of Oncology, Odense University Hospital, Denmark.
P
P
Pfeiffer
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EL
Madsen
O
O
Hansen
O
O
May
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa; D009067:Mouthwashes; D009918:Orbital Neoplasms / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D013280:Stomatitis / Q000139:chemically induced / Q000517:prevention & control*; D013392:Sucralfate / Q000008:administration & dosage / Q000627:therapeutic use*
D009067:Mouthwashes; D001761:Bleomycin; D013392:Sucralfate; D002945:Cisplatin; D005472:Fluorouracil