The combination of metoclopramide, methylprednisolone and ondansetron against antiblastic-delayed emesis: a randomised phase II study.
The aim of the study was to verify whether the combination of an antiserotoninergic, metoclopramide, and a steroid could improve the complete control (CC) of delayed emesis, a contraversial issue, 105 patients undergoing highly-emetogenic chemotherapy, receiving Ondansetron (O) 8 mg + Dexamethasone 20 mg i.v. for the prevention of acute emesis, were randomly treated p.o for three further days with a) Metoclopramide 10 mg x 3 b) the same as a) + Methylprednisolone 4 mg c) the same as b) + O 8 mg x 3. CC (acute+delayed emesis) over three cycles was: a) 0.b) 12.5%, c) 38.5% (p = 0.02). Days with nausea/vomiting: 59%, 51%, 29.7% of the total observed period, respectively (b vs c p = 0.0000). CC of acute emesis was similar in the first cycle (about 85%), remained unchanged in the following cycles (c) and decreased to 30% and 68% in the third cycle (a and b) (p = 0.01). The three drug combination significantly improved complete control of acute and delayed emesis over successive chemotherapy cycles.
Mustacchi
G
G
Centro Oncologico, ASS N 1 Triestina-Università degli Studi, Italia.
Ceccherini
R
R
Leita
M L
ML
Sandri
P
P
Milani
S
S
Carbonara
T
T
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D004359:Drug Therapy, Combination; D006801:Humans; D008775:Methylprednisolone / Q000008:administration & dosage*; D008787:Metoclopramide / Q000008:administration & dosage*; D008875:Middle Aged; D017294:Ondansetron / Q000008:administration & dosage*; D014839:Vomiting / Q000517:prevention & control*
D000970:Antineoplastic Agents; D017294:Ondansetron; D008787:Metoclopramide; D008775:Methylprednisolone