UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005760 |
|---|---|
| Receipt number | R000006808 |
| Scientific Title | Cancer Dyspnea Relief Trial |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2018/09/04 11:47:44 |
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Basic information
Public title
Cancer Dyspnea Relief Trial
Acronym
CDR Trial
Scientific Title
Cancer Dyspnea Relief Trial
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Satoru Tsuneto |
Organization
Osaka University
Division name
Graduate School of Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3867
tsuneto@pm.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yamaguchi |
Organization
Kobe University hospital
Division name
Department of Palliative Medicine
Zip code
Address
7-5-1 Kusunokicho, Chuo ward, Kobe, Hyogo
TEL
078-382-6531
Homepage URL
ikagoro@pop06.odn.ne.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/jjco
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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 12 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006808
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| Registered date | File name |
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| Registered date | File name |
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