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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047815
Receipt No. 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 2022/05/24

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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
Obsterics 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 Parallel
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 8 weeks (8 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 8 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 26

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
Email 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
Email donoyama@k.tsukuba-tech.ac.jp

Sponsor
Institute MEXT(Japan)
Institute
Department

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
Email 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 Preinitiation
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 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 20 Day
Last modified on
2022 Year 05 Month 24 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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