UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006570 |
|---|---|
| Receipt number | R000007780 |
| Scientific Title | Change in level of dyspnea when oral morphine is administered to cancer patients |
| Date of disclosure of the study information | 2011/10/20 |
| Last modified on | 2014/10/18 09:53:29 |
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Basic information
Public title
Change in level of dyspnea when oral morphine is administered to cancer patients
Acronym
Change in level of dyspnea when oral morphine is administered to cancer patients
Scientific Title
Change in level of dyspnea when oral morphine is administered to cancer patients
Scientific Title:Acronym
Change in level of dyspnea when oral morphine is administered to cancer patients
Region
| Japan |
Condition
Condition
Dyspnea in cancer patients
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Change of dyspnea in cancer patients with each background after the oral morphine medication
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intensity of dyspnea before and after the oral morphine medication:
Assessing with Visual Analog Scale (VAS)
Key secondary outcomes
- Change of VAS in each background including causative disorder, baseline opioid, and intensity of baseline dyspnea
- Cancer Dyspnea Scale
- Numeric Rating Scale (NRS)
- Patient's feeling of improvement
- Dyspnea 48 hours after medication
- Adverse events, such as respiratory depression, sleepiness, nausea, and constipation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Primary or metastatic lung cancer
2) Dyspnea at rest
3) Aged 20 years or older
4) Expected to be able to take oral medicine for more than one week
5) Without dementia, impaired consciousness, or delirium
6) Opioid rescue use three times a day or less, No rescue use within four hours
7) Respiratory rate 10/min or more
8) Written informed consent
Key exclusion criteria
1) Clinical condition which can improve with other medication, such as pneumonia or heart failure is predominant.
2) Severe organ disfunction
3) History of serious allergy to morphine
4) Receiving pentazocine or buprenorphine
5) Previous registration history
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kondo Masashi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi 466-8550, Japan
TEL
052-744-2176
mkond@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Takahashi |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, JAPAN
TEL
0564-21-6251
Homepage URL
ktakahashi@acc-aichi.com
Sponsor or person
Institute
Central Japan Lung Study Group (CJLSG)
Institute
Department
Personal name
Funding Source
Organization
Central Japan Lung Study Group (CJLSG)
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 20 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
It is due to start from October, 2011.
Results will be exhibited after analysis.
Management information
Registered date
| 2011 | Year | 10 | Month | 18 | Day |
Last modified on
| 2014 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007780
