UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cancer Dyspnea Relief Trial
Title of the study (Brief title)	CDR Trial
Region	Japan

Condition
Condition	Dyspnea in cancer patient
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of oxycodone to dyspnea in cancer patients with morphine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	mean change in intensity of dyspnea evaluated by NRS at 60 minutes after taking investigational drug in each group.
Key secondary outcomes	(1) mean change in intensity of dyspnea evaluated by NRS at 120 minutes after taking investigational drug in each group. (2)the rate of the patietnts with more than 1 reduction in dyspnea intensity evaluated by NRS at 60 and 120 minutes after taking investigational drug in each group.

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	immediate release oxycodone
Interventions/Control_2	immediate release morphine
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) written consent (2) inpatient or outpatient (3) localy advanced or metastatic disease (4)prescribed SR oxycodone 20-200mg/day for regular analgesics (5) clinically clear consiousness (6) intensity of dyspnea in rest more than 3 in NRS (7) SpO2 > 90%, with supplimental oxygen if needed (8) ECOG PS 0-3
Key exclusion criteria	(1) anemia is a cause of dyspnea (2) acute respiratory failure (3) decompensated heart failure (4) impairment of liver function: 5 times higher than upper normal value of AST or ALT, or total bilirubin > 2mg/dl (5) renal insufficiency : twice higher than upper normal value of Cr (6) bacterial enteritis (7) unstable pain: more than 5 in NRS(0-10) and plan to increase opioid within next 24hr (8) expected prognosis is less than 1 month (9) hypersensitivity to opium alkaloid (10) opioid rescue use for pain within 9 hour before taking investigational drug (11) opioid analgesic use for any symptoms other than pain within 24 hour before taking investigational drug (12) history of taking opioid rescue for dyspnea (13) prescribed codein, morphine, fentanyl, tramadol, or buprenorphine as regular medication (14) those who is considered not to be qualified for this trial by primary responsible doctor
Target sample size	100

Research contact person
Name of lead principal investigator	Satoru Tsuneto
Organization	Osaka University
Division name	Graduate School of Medicine
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3867
Email	tsuneto@pm.med.osaka-u.ac.jp

Public contact
Name of contact person	Takashi Yamaguchi
Organization	Kobe University hospital
Division name	Department of Palliative Medicine
Address	7-5-1 Kusunokicho, Chuo ward, Kobe, Hyogo
TEL	078-382-6531
Homepage URL
Email	ikagoro@pop06.odn.ne.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Japanese Society of Palliative Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

旭川医科大学病院 (北海道) 淀川キリスト教病院 (大阪府) 岡山済生会総合病院 (岡山県) 静岡県立がんセンター (静岡県) 九州がんセンター (福岡県) 山形大学附属病院 (山形県) 手稲渓仁会病院 (北海道) 山形県立中央病院 (山形県) 国立がん研究センター東病院 (千葉県) 県立広島病院 (広島県) 名古屋市立大学病院 (愛知県) 神戸大学医学部附属病院 (兵庫県) 国立病院機構 大阪医療センター (大阪府) 大阪大学附属病院（大阪府） 静岡済生会総合病院 (静岡県) 亀田総合病院 (千葉県) KKR札幌医療センター (北海道) 都立駒込病院 (東京都) 筑波大学附属病院 (茨城県) 東札幌病院 (北海道) 筑波メディカルセンター病院 (茨城県) ガラシア病院 (大阪府) 聖隷三方原病院 (静岡県) 聖隷浜松病院 (静岡県) 新潟市民病院 (新潟県) 佐久総合病院 (長野県) 小牧市民病院 (愛知県) 市立岸和田市民病院（大阪府） 近畿中央胸部疾患センター（大阪府） 近畿大学医学部付属病院（大阪府） 大阪府立呼吸器アレルギー医療センター（大阪府） 関西電力病院（大阪府） 天理よろづ相談所病院（奈良県）

Other administrative information
Date of disclosure of the study information	2011 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 12 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2014 Year 06 Month 30 Day
Date of closure to data entry	2014 Year 06 Month 30 Day
Date trial data considered complete	2016 Year 07 Month 01 Day
Date analysis concluded	2018 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://academic.oup.com/jjco
Results
Other related information

Management information
Registered date	2011 Year 06 Month 12 Day
Last modified on	2018 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006808