A double-blind, crossover study of controlled-release metoclopramide and placebo for the chronic nausea and dyspepsia of advanced cancer

To compare a novel controlled-release formulation of metoclopramide with pl acebo in patients with cancer-associated dyspepsia syndrome, 26 adult patie nts with a greater than or equal to 1 month history of cancer-associated dy spepsia syndrome were randomized to receive either controlled-release metoc lopramide 40 mg every 12 hours or matching placebo for a period of 4 days. On day 5, patients crossed over to the alternate treatment for a further pe riod of 4 days. Dose adjustments and rescue antiemetics were permitted duri ng both phases. Nausea, anorexia, bloating, vomiting/retching, and drowsine ss were assessed on a 100-mm VAS scale in a daily diary. On the last day of treatment of each phase nausea was significantly lower in the controlled-r elease metoclopramide group compared to placebo (17 +/- 12 mm versus 12 +/- 10 mm). Nausea scores tended to increase across days during the placebo ph ase and to decrease during the controlled release metoclopramide phase. The re was a trend for improvement in the intensity of all symptoms on controll ed-release metoclopramide with the exception of appetite, but this trend on ly reached statistical significance nausea. The frequency and severity of e licited adverse events did not differ significantly between treatments, alt hough drowsiness, dizziness, and poor sleep were somewhat higher in the pla cebo group. In no case was it necessary to discontinue controlled-release m etoclopramide because of toxicity. These results indicate that controlled-r elease metoclopramide reduces gastrointestinal symptoms in this population of advanced cancer patients. (C) U.S. Cancer Pain Relief Committee, 2000.