UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a hot compress to the back of the neck on fatigue in patients with cancer chemotherapies for hematologic malignancies.
Title of the study (Brief title)	Effects of a hot compress to the back of the neck on fatigue by the cancer chemotherapies.
Region	Japan

Condition
Condition	Hematologic malignancies
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The study is to reveal the effects of a hot compress to the back of the neck on fatigue in patients with the cancer chemotherapies for himatologic malignancies.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Cancer Fatigue Scale(CFS) evaluation time: Just before intervention, immediately after intervention and after two hours later.
Key secondary outcomes	1.Fatigue Numerical Scale(FNS) 2.Vital sign

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	To do the back of the neck by using the towel warmed to 40 degrees Celsius for 10 minutes.
Interventions/Control_2	To rest on the bed for 10 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.Patients being to receive chemotherapies or patients receiving chemotherapies started within one month. 2.Patients diagnosed with Leukemia or Multiple myeloma or Malignant Lymphoma. 3.FNS score more than four points. 4.patients permited by the chief physician. 5.Patients who consent to participation in the study after explained orally and in writing.
Key exclusion criteria	1.Patients who feel pain for resting on the bed 10 minutes. 2.Patients wound in the back of the neck. 3.Patients assesserd unsuitable by the principal investigation.
Target sample size	15

Research contact person
Name of lead principal investigator	Hitomi Ota
Organization	Yamaguchi University Hospital
Division name	Nursing depertment
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-0057, Japan
TEL	0836-22-2111
Email	hitomi.s@yamaguchi-u.ac.jp

Public contact
Name of contact person	Hitomi Ota
Organization	Yamaguchi University Hospital
Division name	Nursing depertment
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-0057, Japan
TEL	0836-22-2111
Homepage URL
Email	hitomi.s@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Hospital
Institute
Department

Funding Source
Organization	Yamaguchi University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	山口大学医学部付属病院（山口県）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 14 Day
Anticipated trial start date	2017 Year 01 Month 15 Day
Last follow-up date	2017 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 14 Day
Last modified on	2018 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029520