UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023345 |
|---|---|
| Receipt number | R000026902 |
| Scientific Title | Effect of fan for dyspnea in advanced cancer patients: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2018/01/26 11:01:22 |
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Basic information
Public title
Effect of fan for dyspnea in advanced cancer patients: A Randomized Controlled Trial
Acronym
Effect of fan for dyspnea in advanced cancer patients: A Randomized Controlled Trial
Scientific Title
Effect of fan for dyspnea in advanced cancer patients: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of fan for dyspnea in advanced cancer patients: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Advanced Cancer
Classification by specialty
| Hematology and clinical oncology | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the effectiveness of fan to face to reduce the sensation of breathlessness in patients with advanced cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Primary outcome is change in the severity of breathlessness score using a Numerical Rating Score(NRS). NRS assessment are completed before and after the intervention/ control.
Key secondary outcomes
Secondary outcome is proportion of patient experiencing benefit in breathlessness as an absolute fall of 1 point or more on the NRS scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Fan directed to face, the airflow to the region innervated by 2nd and 3rd trigeminal nerve branches, for 5 minutes
Interventions/Control_2
Fan directed to legs for 5 minutes
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. Any patient able and willing to cooperate with the study
2. Patients with metastatic or locally advanced cancer
3. No further or current anticancer treatment
4. ECOG Performance Status = 3 or 4
5. Patients with lucidity and capability of communication in Japanese and without cognitive impairments
6. NRS levels for Dyspnea >= 3
7. SpO2 >= 90
Key exclusion criteria
1. Patients with diseases or treatment affecting the trigeminal nerve supply
2. Hb <= 6
3. Judged to be inappropriate for participation to the study by the attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Kako |
Organization
National Cancer Center Hospital East
Division name
Division of Nursing
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577
TEL
04-7133-1111
jkakoh@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Kako |
Organization
National Cancer Center Hospital East
Division name
Division of Nursing
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577
TEL
04-7133-1111
Homepage URL
jkakoh@east.ncc.go.jp
Sponsor or person
Institute
Division of Nursing, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education,Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
国立がん研究センター東病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | 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
| 2016 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 26 | Day |
Last modified on
| 2018 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026902
