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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025680
Receipt No. R000029520
Scientific Title Effects of a hot compress to the back of the neck on fatigue in patients with cancer chemotherapies for hematologic malignancies.
Date of disclosure of the study information 2017/01/15
Last modified on 2018/01/31

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Basic information
Public title Effects of a hot compress to the back of the neck on fatigue in patients with cancer chemotherapies for hematologic malignancies.
Acronym Effects of a hot compress to the back of the neck on fatigue by the cancer chemotherapies.
Scientific Title Effects of a hot compress to the back of the neck on fatigue in patients with cancer chemotherapies for hematologic malignancies.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hitomi Ota
Organization Yamaguchi University Hospital
Division name Nursing depertment
Zip code
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
1st name
Middle name
Last name Hitomi Ota
Organization Yamaguchi University Hospital
Division name Nursing depertment
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 11 Month 14 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000029520

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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