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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012008
Receipt No. R000014035
Scientific Title Randomized study of prochlorperazine for the prophylaxis of oxycodon induced nausea in patients with cancer related pain
Date of disclosure of the study information 2013/10/10
Last modified on 2018/02/20

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Basic information
Public title Randomized study of prochlorperazine for the prophylaxis of oxycodon induced nausea in patients with cancer related pain
Acronym Prophylaxis use of prochloroperazine
Scientific Title Randomized study of prochlorperazine for the prophylaxis of oxycodon induced nausea in patients with cancer related pain
Scientific Title:Acronym Prophylaxis use of prochloroperazine
Region
Japan

Condition
Condition advanced cancer
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of prophylaxis use of prochlorperazine in cancer patient with the first use of opioid (oxycodone)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes The worst value of nausea (evaluated by NRS 0-10 of MDASI) during the first 7 days after the start of protocol treatment.
Key secondary outcomes 1) Number of vomiting during the first 7 days after the start of protocol treatment.
2) Proportion of patients who could not continue taking oxycodone due to nausea
3) The worst value of pain, sleepness, malaise, sleep disorder, and loss of appetite (evalueted by NRS 0-10 of MDASI) during the first 7 days after the start of protocol treatment.
4) Proportion of patients using anti-emesis medication
5) Adverse events of prochlorperazine

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Combination group
Oxycontine 5mgq12hr in combination with
prochlorperazine maleate 5mg t.i.d.
Interventions/Control_2 Standard group
Oxycontine 5mgq12hr after the emergence of nausea,
prochlorperazine maleate 5mg
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Agreement by patients to participate in this study.
2) Histologically or cytologically confirmed cancer.
3) ECOG performance status 0-3.
4) More than 7 days lapse after chemotherapy or radiation therapy.
5) Patient to start the opioid treatment (morphine, oxycodone, fentanyl) for the treatment of cancer pain and start periodic use of oxycodone 5mg bid (As needed use of potent opioid is permitted).
6) 20 years old or older.
7) Patient who can safely take oral mediation.
8) Expected survival of >= 4 weeks.
9) Patient who can keep a patient diary.
10) Patient has the following blood chemistry levels at baseline:
AST (SGOT) <= 100IU/L
ALT (SGPT) <= 100 IU/L
TB <= 2.25 mg/dL
creatinine <= 2.0 mg/dL.
Key exclusion criteria 1) Patients in need of anti-emesis medication (roughly >= NRS 3)
Anti-emesis medication: prochlorperazine, metoclopramide, itopride, Mosapride citrate hydrate, Sulpiride, steroid
2) Episode of vomiting within 48hrs before registration
3) Patients with dementia, delirium, depressed level of consciousness, communication disorder due to aphasia, dyslexia, dysarthria etc
4) Patients with severe infection
5) Hypercalcemia (adjusted Ca conc (Ca mg/dL +(4-Alb)>11mg/dL)
6) Patient with ileus
7) Symptomatic brain metastasis
8) Patients who are planned to start chemotherapy or radiation therapy in purpose for palliation cancer pain, before the improvement of cancer pain by this protocol treatment.
9) Comorbidity which treatments take priority over cancer treatment.
10) Increase, decrease, cessation of hyptonic, anti-anxiety agent (tricyclic or tetracyclic, anti depressant, SNRI, SSRI, etc), psychotropic agent, anticonvulsant agent, ketamine hydrochloride) within 24hrs before registration
11) Patients taking adrenalin
12) Patients who are suspicious of sub-cortex brain disorder
13) Patients taking anticholinergic agent, triazole antifungal antibiotics
14) Patient who were judged to be ineligible by the doctor
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Goto
Organization National Cancer Center Hospital
Division name Department of Thoracic Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, JAPAN
TEL 03-3542-2511
Email ygoto-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Goto
Organization National Cancer Center Hospital
Division name Department of Thoracic Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, JAPAN
TEL 03-3542-2511
Homepage URL http://www.jortc.jp/
Email ygoto-tky@umin.net

Sponsor
Institute Non-Profit Organization JORTC
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Terminated
Date of protocol fixation
2013 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 10 Day
Last modified on
2018 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014035

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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