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Edema Control in Patients With Breast Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
self massage
manual lymph drainage
epidermis fascia taping
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Edema,taping,ultrasound

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  1. age:20~80 y/o
  2. female patients with unilateral breast cancer after surgery
  3. unilateral lymph edema ( circumference of affected side 2cm bigger than sound side）
  4. do not receive any treatment of lymph edema Exclusion criteria

1. skin problems on affected side 2. neurological sign involved affected side, ex:stroke, brachial plexus impairment 3. involved other diseases may cause extremity edema, ex: heart failure or chronic kidney disease (stage one to stage five) 4. have medicine which may cause extremity edema 5. pregnant

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

control group

manual lymph drainage group

experimental group

Arm Description

self massage, skin care education, manual lymph drainage exercise, compression garment

manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment

epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment

Outcomes

Primary Outcome Measures

thickness of epidermis and dermis

Secondary Outcome Measures

Full Information

First Posted
March 9, 2016
Last Updated
March 15, 2016
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02707835
Brief Title
Edema Control in Patients With Breast Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping
Official Title
The Effect of Edema Control in Patients With Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping With Ultrasonography
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The ultrasound imaging could be used to examine the thickness of dermis and the space between dermis and subcutaneous tissue. Whether the measurement of ultrasound imaging correlate to other measurement of edema is unknown. The purpose of this study is to investigate The reliability of measurement of edema using ultrasound imaging, and the correlation of measurement of ultrasound with other measurement tools. The different effect of edema control by manual lymph drainage technique and epidermis taping technique, and the cost-effective assessment. Our hypothesis : The measurement of edema with ultrasound imaging is a reliable method and correlate with other edema measurement with moderate correlation. Ultrasound measurement could demonstrate different effect of manual lymph drainage and epidermis taping, and different cost-effectiveness analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Edema,taping,ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
self massage, skin care education, manual lymph drainage exercise, compression garment
Arm Title
manual lymph drainage group
Arm Type
Active Comparator
Arm Description
manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
Arm Title
experimental group
Arm Type
Experimental
Arm Description
epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
Intervention Type
Other
Intervention Name(s)
self massage
Intervention Description
self massage, skin care education, manual lymph drainage exercise, compression garment
Intervention Type
Other
Intervention Name(s)
manual lymph drainage
Intervention Description
manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
Intervention Type
Other
Intervention Name(s)
epidermis fascia taping
Intervention Description
epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
Primary Outcome Measure Information:
Title
thickness of epidermis and dermis
Time Frame
10 mins

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: age:20~80 y/o female patients with unilateral breast cancer after surgery unilateral lymph edema ( circumference of affected side 2cm bigger than sound side） do not receive any treatment of lymph edema Exclusion criteria 1. skin problems on affected side 2. neurological sign involved affected side, ex:stroke, brachial plexus impairment 3. involved other diseases may cause extremity edema, ex: heart failure or chronic kidney disease (stage one to stage five) 4. have medicine which may cause extremity edema 5. pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing-Lan Yang
Phone
886-2-23123456-67564
Email
yangjinglan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
SHU-FEN WANG, PhD
Phone
886-972651068
Email
shwufenwang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-Lan Yang
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-Lan Yang
Phone
886-2-23123456-67564
Email
yangjinglan@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Edema Control in Patients With Breast Cancer-comparison of Manual Lymph Drainage and Epidermis Fascia Taping

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