UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007616 |
|---|---|
| Receipt number | 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 13:44:09 |
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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
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
Sponsor or person
Institute
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008992
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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