Protective efficacy of the prochlorperazine for oxycodone-induced nausea and vomiting for patients with cancer pain Randomized placebo control double-blind trial (phase III study)

INTERVENTION: The study drug group assumes prochlor perazine(5 mg of Novamin locks) internal use after a meal three times a day for five days. Placebo assumes placebo internal use after a meal three times a day for five days. CONDITION: Cancer pain PRIMARY OUTCOME: The primary outcome set nausea during study period with complete response rate (CR rate) of the vomiting‐related event.; "There was not a vomiting‐related event" and defined it as the patients that "there was not relief treatment for nausea" with CR. SECONDARY OUTCOME: (1); Time of onset until an initial "vomiting‐related event"; The time when the first "vomiting‐related event" developed from study drug initiation; (2); Time before using antiemetics rescue from study drug initiation for the first time at the first time to "antiemetics relief treatment"; (3); "There is no vomiting‐related event"; population of patients; Ratio of patients that there was not "a vomiting‐related event" during study period; (4); The number of times of "the vomiting‐related event"; We assume "a vomiting‐related event" 1 episode and count 1 episode with once.; However, we include it in 1 episode when we show a similar vomiting‐related event within five minutes.; (5); "There is no nausea"; population of patients; Ratio of patients of "(for the patients of study initiation time CTC‐AE Grade1) whom "there is no nausea" after study drug initiation or there is no exacerbation of nausea" in; (6); Degree of "nausea"; We evaluate severest "nausea" in NRS every 24 hours and evaluate it on average of 5 days.; (7); Ratio of patients who "there was no antiemetics relief treatment", and did not use population of patients antiemetics rescue; (8); The number of times of "the antiemetics relief treatment"; Use of the antiemetics rescue; (9); Consumption of opioids; Gross weight (including the relief treatment) of the opioids which we used; (10); Change of the quantity of diet; (11); Quality of life evaluation; We evaluate it in EORTC QLQ‐C15‐PAL.; (12); Adverse event INCLUSION CRITERIA: (1)Patients with cancer that the internal use of the oxycodone is necessary for treatment of cancer pain (2) It is expected that internal use of the oral medication can maintain a possible state for one week (3) We are 20 years old or older (4) A document agreement by the free will of the patients person himself is obtained in the thing which understands it enough after having received enough explanation on participating of this study (5) Survival one month or more is expected from a registration day (6) The latest laboratory values within one month before registration meet the following criteria 1) 5 times * 1 of the AST(GOT) <= institution reference value 2) 5 times * 1 of the ALT (GPT) <= institution reference value * When we judge it including the patients with 1 liver metastasis and the patients with biliary system tumor including the pancreatic cancer when a medical attendant is suitable when it is a refere