A randomized, double-blind, cross-over study comparing a levosulpiride-based and a metoclopramide-based combination in the prevention of ProMECE-CytaBOM-induced emesis

Haematologica. 1995 Sep-Oct;80(5):416-20.

Abstract

Background: To test two different antiemetic regimens for preventing nausea and vomiting in patient with non-Hodgkin's lymphoma (NHL) undergoing systemic chemotherapy (CT) with ProMECE-CytaBOM (P-C).

Patients and methods: Twenty consecutive untreated adult outpatients with histologically confirmed NHL and scheduled to receive P-C chemotherapy were registered in a randomized, double-blind, cross-over study to compare the antiemetic efficacy of a levosulpiride (LS)-based and metoclopramide (MTC)-based regimen.

Results: Complete protection from vomiting was recorded in 93% (62/67) of courses with the LS-regimen and in 89% (62/70) with the MTC-regimen (p = 0.428). No nausea was observed in 84% (56/67) of courses with the LS-regimen and in 74% (52/70) with the MTC-regimen (p = 0.183). No differences in prevention of emesis were recorded when patients crossed to the other regimen. Both regimens were well tolerated; however, on day 8 of chemotherapy, when both antiemetic regimens were administered at a higher dose, the LS-based combination showed significantly lower toxicity (p = 0.035).

Conclusions: ProMECE-CytaBOM-induced emesis can be prevented in most cases with appropriate, specifically designed antiemetic therapy. Both the LS- and MTC-based combinations resulted in a high percentage of complete protection from emesis, but the higher incidence of side effects observed with MTC makes the LS-based regimen preferable for patients receiving P-C chemotherapy.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antiemetics / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Basal Ganglia Diseases / chemically induced
  • Bleomycin / administration & dosage
  • Bleomycin / adverse effects
  • Cross-Over Studies
  • Cyclophosphamide / administration & dosage
  • Cyclophosphamide / adverse effects
  • Cytarabine / administration & dosage
  • Cytarabine / adverse effects
  • Diazepam / administration & dosage
  • Diazepam / analogs & derivatives
  • Diazepam / therapeutic use
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Epirubicin / administration & dosage
  • Epirubicin / adverse effects
  • Etoposide / administration & dosage
  • Etoposide / adverse effects
  • Humans
  • Lymphoma, Non-Hodgkin / complications
  • Lymphoma, Non-Hodgkin / drug therapy*
  • Methotrexate / administration & dosage
  • Methotrexate / adverse effects
  • Metoclopramide / administration & dosage
  • Metoclopramide / adverse effects
  • Metoclopramide / therapeutic use*
  • Middle Aged
  • Nausea / chemically induced
  • Nausea / prevention & control
  • Prednisone / administration & dosage
  • Prednisone / adverse effects
  • Prochlorperazine / administration & dosage
  • Prochlorperazine / therapeutic use
  • Promethazine / administration & dosage
  • Promethazine / therapeutic use
  • Sulpiride / administration & dosage
  • Sulpiride / adverse effects
  • Sulpiride / analogs & derivatives*
  • Sulpiride / therapeutic use
  • Treatment Outcome
  • Vincristine / administration & dosage
  • Vincristine / adverse effects
  • Vomiting / chemically induced
  • Vomiting / prevention & control*

Substances

  • Antiemetics
  • Cytarabine
  • Bleomycin
  • Epirubicin
  • Vincristine
  • Etoposide
  • Sulpiride
  • Cyclophosphamide
  • Promethazine
  • levosulpiride
  • Metoclopramide
  • Diazepam
  • Prednisone
  • Prochlorperazine
  • Methotrexate

Supplementary concepts

  • ProMECE-CytaBOM protocol