UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	POINT study
Region	Japan

Condition
Condition	Cancer pain
Classification by specialty	Not applicable Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In the patients with cancer pain, we evaluate the advantage for the placebo group of the prochlorperazine by a placebo-controlled double-blind randomized controlled trial for the prevention of oxycodone-induced nausea, vomiting.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes	(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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The study drug group assumes prochlor perazine(5 mg of Novamin locks) internal use after a meal three times a day for five days.
Interventions/Control_2	Placebo assumes placebo internal use after a meal three times a day for five days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	100 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	120

Research contact person
Name of lead principal investigator	Yuichi Ando
Organization	Nagoya University Hospital
Division name	Department of Clinical Oncology and Chemotherapy
Address	65, Tsurumaicho, Syowa-ku, Nagoya-shi, Aichi
TEL	0527441902
Email	yando@med.nagoya-u.ac.jp

Public contact
Name of contact person	Hiroaki Tsukuura
Organization	Nagoya University Hospital
Division name	Department of Clinical Oncology and Chemotherapy
Address	65, Tsurumaicho, Syowa-ku, Nagoya-shi, Aichi
TEL	0527441902
Homepage URL
Email	tsuku@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital Department of Clinical Oncology and Chemotherapy
Institute
Department

Funding Source
Organization	Nagoya University Hospital Department of Clinical Oncology and Chemotherapy
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Grant for Research Advancement on Palliative Medicine, Japanese Society for Palliative Medicine

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 05 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 11 Month 11 Day
Anticipated trial start date	2013 Year 12 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 05 Day
Last modified on	2016 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013926