Sustained-release metoclopramide plus methylprednisolone versus placebo plus methylprednisolone as antiemetic prophylaxis during non-cisplatin chemotherapy. A randomized double-blind cross-over trial.
In a randomized double-blind cross-over trial, sustained-release metoclopramide (S) plus methylprednisolone (M) was compared with placebo (P) plus methylprednisolone as antiemetic prophylaxis during two cycles of non-cisplatin chemotherapy. S was administered as 60 mg every 12 h commencing on the evening before chemotherapy up to total of 300 mg metoclopramide in 2.5 days. Evaluation of nausea and vomiting was done by self-assessment schemes and visual analog scales. Fifty patients were included and 36 fulfilled both cycles. Mild nausea and vomiting were experienced by 81% and 83% in the S + M and P + M groups, respectively, while 42% and 39% showed complete control of nausea and vomiting during the first day of treatment. Moderate-dose S did not add to the antiemetic efficacy of M in non-cisplatin chemotherapeutic regimens.
Hansen
O
O
Department of Oncology, Odense University Hospital, Odense, Denmark.
Pfeiffer
P
P
Madsen
B
B
Andersen
I
I
Hansen
B
B
Mathiesen
B
B
D000328:Adult; D000932:Antiemetics / Q000097:blood / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy; D018567:Breast Neoplasms, Male / Q000188:drug therapy; D018890:Chemoprevention; D002945:Cisplatin / Q000008:administration & dosage; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use*; D008787:Metoclopramide / Q000097:blood / Q000627:therapeutic use*; D009325:Nausea / Q000517:prevention & control; D010051:Ovarian Neoplasms / Q000188:drug therapy; D012647:Self-Assessment; D014839:Vomiting / Q000517:prevention & control
D000932:Antiemetics; D003692:Delayed-Action Preparations; D008787:Metoclopramide; D002945:Cisplatin; D008775:Methylprednisolone