Annals of Oncology 1: 379-380,1990. © 1990 Kluwer Academic Publishers. Printed in the Netherlands.
Short report Randomized, double-blind cross-over study of acute cisplatin-induced nausea and vomiting, comparing a new schedule of the combination of metoclopramide and methylprednisolone versus metoclopramide alone E. Diaz-Rubio, J.L. Gonzalez-Larriba, R. Rosell, A. Abad, M. Martin, JJ. Valerdi & JJ. Barriga Hospital Universitario San Carlos, Madrid; Hospital Germans Trias y Pujol, Badalona; Hospital General de Navarra, Pamplona; Upjohn Medical Department, Madrid, Spain
Key words: cisplatin-induced nausea and vomiting, methylprednisolone, metoclopramide
Introduction
Results
Several trials have indicated that corticosteroids such as dexamethasone or methylprednisolone (MP) are capable of enhancing the anti-emetic effect of metoclopramide (MTC) in Cisplatin-induced nausea and vomiting [1-5]. On the basis of these trials we started a randomized trial comparing the combination of MTC plus MP, versus MTC plus placebo, in a regimen which included only two intravenous administrations of each of these agents.
The characteristics of the 78 patients who entered the trial are shown in Table 1. Of these, 71 were evaluable, 6 being excluded because of tumour progression after the first cycle, and one because of refusal of chemotherapy. An additional patient was unable to fill out the questionnaire for assessment of nausea and was therefore assessed for emesis only. Table 1. Patient characteristics.
Materials and methods After having given written consent, 78 patients with various types of cancer who were being treated with cisplatin (CDDP) infused over one hour, alone or in combination, entered a randomized, double-blind, cross-over trial comparing MTC+placebo (MTC: 3 mg/kg i.v. in 100 ml 0.9% saline solution in a 15-minute infusion, 30 minutes before the administration of CDDP and 1 1/2 hours afterwards), with MTC (same dose) plus MP (250 mg in 100 ml saline solution by intravenous route in a half-hour infusion after each administration of MTC). None of the patients had had prior chemotherapy, and all were treated in an inpatient setting. Each patient served as his/her own control. The randomization procedure and the coding of preparations were performed at the Upjohn Department, and the code remained unbroken until completion of the study. In the second cycle of chemotherapy the patients received the alternative treatment. The efficacy of the anti-emetic treatment was defined as: complete protection (0 emetic episodes), major protection (1-2 emetic episodes), minor protection (3-5 emetic episodes) and failure (more than 5 emetic episodes). The intensity of nausea was assessed according to the following scale: 0: no nausea, 1: slight nausea, 2: moderate nausea and 3: severe nausea. The chi-square test for paired data was used for statistical analysis.
MTC+MP
MTC+Placebo
Total
Number of patients
40
38
78
Evaluable Emesis Nausea
36
35
35 35
71 70
Age (Sex: MenWomen) 2(M9 50-64 ;>65
13 (9/4) 18(13/5) 9(5/4)
9 (5/4) 20(12/8) 9(6/3)
22(14/8) 38 (25/13) 18(11/7)
Sex Men Women
27 13
23 15
50 28
25 15
21 17
46 32
Type of tumour Head and neck Ovary Lung Bladder Colon Cervix Esophagus Testicle
16 11 7 2 2 1 0 0
12 13 7 1 2 2 1 1
28 24 14 3 4 3 1 1
Dose of cisplatin
Short report Randomized, double-blind cross-over study of acute cisplatin-induced nausea and vomiting, comparing a new schedule of the combination of metoclopramide and methylprednisolone versus metoclopramide alone E. Diaz-Rubio, J.L. Gonzalez-Larriba, R. Rosell, A. Abad, M. Martin, JJ. Valerdi & JJ. Barriga Hospital Universitario San Carlos, Madrid; Hospital Germans Trias y Pujol, Badalona; Hospital General de Navarra, Pamplona; Upjohn Medical Department, Madrid, Spain
Key words: cisplatin-induced nausea and vomiting, methylprednisolone, metoclopramide
Introduction
Results
Several trials have indicated that corticosteroids such as dexamethasone or methylprednisolone (MP) are capable of enhancing the anti-emetic effect of metoclopramide (MTC) in Cisplatin-induced nausea and vomiting [1-5]. On the basis of these trials we started a randomized trial comparing the combination of MTC plus MP, versus MTC plus placebo, in a regimen which included only two intravenous administrations of each of these agents.
The characteristics of the 78 patients who entered the trial are shown in Table 1. Of these, 71 were evaluable, 6 being excluded because of tumour progression after the first cycle, and one because of refusal of chemotherapy. An additional patient was unable to fill out the questionnaire for assessment of nausea and was therefore assessed for emesis only. Table 1. Patient characteristics.
Materials and methods After having given written consent, 78 patients with various types of cancer who were being treated with cisplatin (CDDP) infused over one hour, alone or in combination, entered a randomized, double-blind, cross-over trial comparing MTC+placebo (MTC: 3 mg/kg i.v. in 100 ml 0.9% saline solution in a 15-minute infusion, 30 minutes before the administration of CDDP and 1 1/2 hours afterwards), with MTC (same dose) plus MP (250 mg in 100 ml saline solution by intravenous route in a half-hour infusion after each administration of MTC). None of the patients had had prior chemotherapy, and all were treated in an inpatient setting. Each patient served as his/her own control. The randomization procedure and the coding of preparations were performed at the Upjohn Department, and the code remained unbroken until completion of the study. In the second cycle of chemotherapy the patients received the alternative treatment. The efficacy of the anti-emetic treatment was defined as: complete protection (0 emetic episodes), major protection (1-2 emetic episodes), minor protection (3-5 emetic episodes) and failure (more than 5 emetic episodes). The intensity of nausea was assessed according to the following scale: 0: no nausea, 1: slight nausea, 2: moderate nausea and 3: severe nausea. The chi-square test for paired data was used for statistical analysis.
MTC+MP
MTC+Placebo
Total
Number of patients
40
38
78
Evaluable Emesis Nausea
36
35
35 35
71 70
Age (Sex: MenWomen) 2(M9 50-64 ;>65
13 (9/4) 18(13/5) 9(5/4)
9 (5/4) 20(12/8) 9(6/3)
22(14/8) 38 (25/13) 18(11/7)
Sex Men Women
27 13
23 15
50 28
25 15
21 17
46 32
Type of tumour Head and neck Ovary Lung Bladder Colon Cervix Esophagus Testicle
16 11 7 2 2 1 0 0
12 13 7 1 2 2 1 1
28 24 14 3 4 3 1 1
Dose of cisplatin
