UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012008 |
|---|---|
| Receipt number | 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 15:46:58 |
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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
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/
ygoto-tky@umin.net
Sponsor or person
Institute
Non-Profit Organization JORTC
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014035
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| Registered date | File name |
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