UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025680
Receipt number 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 16:54:18

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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 or person

Institute

Yamaguchi University Hospital

Institute

Department

Personal name



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

Value
https://center6.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