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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007616
Receipt No. R000008992
Scientific Title Long-term effectiveness of self care program using aromatherapy and excercise for breast-cancer-treatment-related lymphedema
Date of disclosure of the study information 2012/03/30
Last modified on 2013/08/08

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Basic information
Public title Long-term effectiveness of self care program using aromatherapy and excercise for breast-cancer-treatment-related lymphedema
Acronym Long-term effectiveness of self care program for breast-cancer-treatment-related lymphedema
Scientific Title Long-term effectiveness of self care program using aromatherapy and excercise for breast-cancer-treatment-related lymphedema
Scientific Title:Acronym Long-term effectiveness of self care program for breast-cancer-treatment-related lymphedema
Region
Japan

Condition
Condition Breast-cancer-treatment-related-lymphedema
Classification by specialty
Surgery in general Breast surgery Dermatology
Rehabilitation medicine Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the long-term effectiveness of self care program using aromatherapy and simple exercise for breast-cancer-treatment-related lymphedema.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Relative volume change in upper limb
Key secondary outcomes 1)upper limb volume
2)upper volume excess
3)tissue resistance in upper limb
4)lymphedema related symptoms
5)lymphedema self care
6)incidence of acute inflammation
7)skin condition

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 self care program consisted of skin care and lymphatic self drainage using aromatherapy and exercise
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 Female
Key inclusion criteria 1)unilateral breast-cancer-treatment-related lymphedema
2)>6month from active treatment
3)ECOG PS 0-2
4)CTCAE v4.0 edema:limb Grade1-2
5)able to responding questionnaire and self care
6)submitted written consent as a participant
Key exclusion criteria 1)Any sign of skin damage or sign of acute inflammation on affected arm
2)cancer recurrence
3)allegic to aromatherapy
4)pregnant or attempting conception
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiko Sato
Organization Health Science, Graduate School of Medicine, Tohoku University
Division name Oncology nursing
Zip code
Address 2-1Seiryo-machi, Aoba-ku, Sendai, MIYAGI JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Arinaga
Organization Health Science, Graduate School of Medicine, Tohoku University
Division name Oncology nursing
Zip code
Address 2-1Seiryo-machi, Aoba-ku, Sendai, MIYAGI JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.lymphormation.org/journal/view-journal-contents.php?journalId=14&returnUrl=/journal-of-lymphoedema-archive.php
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 No longer recruiting
Date of protocol fixation
2012 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 27 Day
Last follow-up date
2013 Year 12 Month 07 Day
Date of closure to data entry
2013 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2014 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 30 Day
Last modified on
2013 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008992

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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