UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047815 |
|---|---|
| Receipt number | R000054510 |
| Scientific Title | Effectiveness of anma massage therapy for lymphedema in survivors of gynecologic cancer |
| Date of disclosure of the study information | 2022/05/20 |
| Last modified on | 2022/11/23 14:11:16 |
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Basic information
Public title
Effectiveness of anma massage therapy for lymphedema in survivors of gynecologic cancer
Acronym
Anma massage for lymphedema in survivors of gynecologic cancer
Scientific Title
Effectiveness of anma massage therapy for lymphedema in survivors of gynecologic cancer
Scientific Title:Acronym
Anma massage for lymphedema in survivors of gynecologic cancer
Region
| Japan |
Condition
Condition
lymphedema
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to explore the effectiveness of anma massage therapy for postoperative lymphedema in survivors of gynecologic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Lower limb circumference (five circumference measurements: from the head of the first metatarsal to head of the fifth metatarsal; at the ankle, from the lateral to medial malleolus; 5 cm below head of the fibula; 10 cm above the top of the patella; and at the thigh, at the point of the greater trochanter)
We measure before and after the intervention/control duration, and also measure before and after each session.
Key secondary outcomes
1) Quality of life, measured using a self-administered questionnaire, the Japanese version of Quality of Life Measurement for Limb Lymphedema (J-LYMQOL).
2) Blood flow velocity in the great saphenous vein, measured using a bidirectional vascular Doppler.
We measure before and after the intervention/control duration.
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Anma massage therapy + usual care for lymphedema (wearing an elastic stocking): A 60-min whole-body anma massage session administered once a week for 6 weeks (6 sessions in total). Sessions are followed by our anma massage protocol modified specifically for lymphedema.
Interventions/Control_2
Usual care for lymphedema (wearing an elastic stocking) for 4 weeks.
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
Diagnosis of gynecologic cancer and completion of standard medical treatment, with subsequent development of lymphedema
Key exclusion criteria
1) Not completed standard medical treatment or currently undergoing chemotherapy or radiotherapy.
2) Inflammatory disorder of the lower limb, such as cellulitis, lymphangitis, and acute dermatitis
3) Deep vein thrombosis
4) Serious cardiac disease
5) Other disease that contraindicates anma massage therapy, such as severe dementia, severe kidney disease, and inflammatory disorder in other organs
6) Deemed ineligible to participate this study by a medical doctor (Research Collaborator)
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Nozomi |
| Middle name | |
| Last name | DONOYAMA |
Organization
Tsukuba University of Technology
Division name
Department of Health, Faculty of Health Sciences
Zip code
305-8521
Address
4-12-7 Kasuga, Tsukuba, Ibaraki 305-8521, Japan.
TEL
+81-29-858-9631
donoyama@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | DONOYAMA |
Organization
Tsukuba University of Technology
Division name
Department of Health, Faculty of Health Sciences
Zip code
305-8521
Address
4-12-7 Kasuga, Tsukuba, Ibaraki 305-8521, Japan.
TEL
+81-29-858-9631
Homepage URL
donoyama@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
MEXT(Japan)
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Commitee, Tsukuba University of Technology
Address
4-12-7 Kasuga, Tsukuba, Ibaraki 305-8521, Japan.
Tel
+81-29-858-9596
iji@ad.tsukuba-tech.ac.jp
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
筑波技術大学（茨城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Due to upset for participants' recruitment, the registration of modification of the study design was submitted, and approved by the Medical Ethics Commitee, Tsukuba University of Technology on 27 July, 2022.
Management information
Registered date
| 2022 | Year | 05 | Month | 20 | Day |
Last modified on
| 2022 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054510
| 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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| Registered date | File name |
