Cancer pain
Conditions
Interventions
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
Sponsors
Nagoya University Hospital Department of Clinical Oncology and Chemotherapy
Eligibility
Sex/Gender
All
Inclusion criteria
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 reference value or more, the registration is possible. However, it is assumed that, in that case, it is Grade3 or less in CTC-AE. 3) Creatinine clearance >= 30ml/min( calculated value or actual value) * 2 * Male Ccr (ml/min)= weight (kg) X (140-age) / (72* serum creatinine (mg/dl)) which is carried out using expression of Cockcroft-Gault about the calculated value of 2 creatinine clearance ) Female Ccr (ml/min)= men Ccr *0.85 4) 3 times of the total bilirubin levels <= institution reference value
Exclusion criteria
Exclusion criteria: (1)PS (performance status) 4 patients) of ECOG(Eastern Cooperative Oncology Group) (2)The patients whom condition is unstable in for digestive system disease (including reflux oesophagitis, a gastric ulcer, gastrointestinal obstruction, constipation) (3)There is the electrolyte abnormality with "nausea (CTC-AE Grade2 )" or "the vomiting-related event" the patients (4)With "nausea (CTC-AE Grade2 )" or "the vomiting-related event" by other causes the patients (5)The patients with a symptomatic central nerve lesion (including brain metastasis, cancer-related meningitis) (6)We correct the patients who they received head, abdomen (it is assumed that it is lower than diaphragm) or pelvic radiotherapy during - study period six days ago or are going to receive it with study drug initiation, and, as for the localized radiotherapy, combination is possible on the bone part with bone metastases (7)Within 48 hours before study drug initiation, it is the patients using the drug (including a digitalis, the chalybeate) with the emetic action. However, it is excluded when we use it regularly for more than study drug initiation one week (8)Within 48 hours before study drug initiation, it is the patients using the drug with the antiemetic activity. (9)It is the patients who used a medical drug in treatment regularly with cancer pain within three months before registration. (10)It is the patients with a history of hypersensitivity to a prochlorperazine (11)Patients to be contraindicated to prochlorperazine (12)It is the patients with a history of QTc prolongation (QTc> 470msec) with a past electrocardiogram. However, when there is no QTc prolongation in the electrocardiogram within three months before registration, registration is possible (13)The patients with other serious complications (14)Within one week before study drug initiation, it is the patients using an anticancer drug or the molecular target medicine with non-administration in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactHiroaki Tsukuura
Nagoya University Hospital Department of Clinical Oncology and Chemotherapy
Outcome results
None listed