UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of effect of fan for dyspnea in advanced cancer patients
Title of the study (Brief title)	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	Jun Kako
Organization	National Cancer Center Hospital East
Division name	Division of Nursing
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577
TEL	04-7133-1111
Email	jkakoh@east.ncc.go.jp

Public contact
Name of contact person	Jun Kako
Organization	National Cancer Center Hospital East
Division name	Division of Nursing
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577
TEL	04-7133-1111
Homepage URL
Email	jkakoh@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022082