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)

Not Applicable

• Conditions: Cancer pain

• Registration Number: JPRN-UMIN000012502
• Lead Sponsor: agoya University Hospital Department of Clinical Oncology and Chemotherapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.