UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized study of prochlorperazine for the prophylaxis of oxycodon induced nausea in patients with cancer related pain
Title of the study (Brief title)	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	Yasushi Goto
Organization	National Cancer Center Hospital
Division name	Department of Thoracic Oncology
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, JAPAN
TEL	03-3542-2511
Email	ygoto-tky@umin.net

Public contact
Name of contact person	Yasushi Goto
Organization	National Cancer Center Hospital
Division name	Department of Thoracic Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 04 Month 25 Day
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

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Publication of results	Unpublished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