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
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
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
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
