UMIN-CTR Clinical Trial

Public title

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)

Acronym

POINT study

Scientific Title

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)

Scientific Title:Acronym

POINT study

Region

Japan

Condition

Cancer pain

Classification by specialty

Not applicable

Adult

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yuichi Ando

Organization

Nagoya University Hospital

Division name

Department of Clinical Oncology and Chemotherapy

Zip code

Address

65, Tsurumaicho, Syowa-ku, Nagoya-shi, Aichi

TEL

0527441902

Email

yando@med.nagoya-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroaki Tsukuura

Organization

Nagoya University Hospital

Division name

Department of Clinical Oncology and Chemotherapy

Zip code

Address

65, Tsurumaicho, Syowa-ku, Nagoya-shi, Aichi

TEL

0527441902

Homepage URL

Email

tsuku@med.nagoya-u.ac.jp

Institute

Nagoya University Hospital Department of Clinical Oncology and Chemotherapy

Institute

Department

Personal name

Organization

Nagoya University Hospital Department of Clinical Oncology and Chemotherapy

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Grant for Research Advancement on Palliative Medicine, Japanese Society for Palliative Medicine

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名古屋大学医学部附属病院

Date of disclosure of the study information

2013

Year

12

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2013

Year

11

Month

11

Day

Date of IRB

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

Other related information

Registered date

2013

Year

12

Month

05

Day

Last modified on

2016

Year

12

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013926