UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019100 |
|---|---|
| Receipt number | R000022082 |
| Scientific Title | A pilot study of effect of fan for dyspnea in advanced cancer patients |
| Date of disclosure of the study information | 2015/09/24 |
| Last modified on | 2018/03/27 21:28:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A pilot study of effect of fan for dyspnea in advanced cancer patients
Acronym
A pilot study of effect of fan for dyspnea in advanced cancer patients
Scientific Title
A pilot study of effect of fan for dyspnea in advanced cancer patients
Scientific Title:Acronym
A pilot study of effect of fan for dyspnea in advanced cancer patients
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 determine the potential effectiveness of a fan to relieve breathlessness with advanced cancer patients and how long this beneficial effect lasts.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The length of time for NRS levels for dyspnea to return to baseline after use of the fan
Key secondary outcomes
1. Differences in the mean score changes of NRS for dyspnea
2. Differences in the mean score changes of surface temperature in the region innervated by 2nd and 3rd trigeminal nerve branches
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
3 patterns of intervention will be performed
1. No fan for 5 minutes
2. Fan directed to face, the airflow to the region innervated by 2nd and 3rd trigeminal nerve branches, for 5 minutes
3. Fan directed to legs for 5 minutes
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. 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
10
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, 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, Chiba, 277-8577
TEL
04-7133-1111
Homepage URL
jkakoh@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
the Yasuda Medical Foundation
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
国立研究開発法人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
| 2015 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 24 | Day |
Last modified on
| 2018 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022082
