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

March 15, 2016 updated by: National Taiwan University Hospital

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

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

  1. The reliability of measurement of edema using ultrasound imaging, and the correlation of measurement of ultrasound with other measurement tools.
  2. The different effect of edema control by manual lymph drainage technique and epidermis taping technique, and the cost-effective assessment.

Our hypothesis :

  1. The measurement of edema with ultrasound imaging is a reliable method and correlate with other edema measurement with moderate correlation.
  2. Ultrasound measurement could demonstrate different effect of manual lymph drainage and epidermis taping, and different cost-effectiveness analysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
self massage, skin care education, manual lymph drainage exercise, compression garment
Other: self massage
self massage, skin care education, manual lymph drainage exercise, compression garment
Active Comparator: manual lymph drainage group
manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
Other: manual lymph drainage
manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
Experimental: experimental group
epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
Other: epidermis fascia taping
epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
thickness of epidermis and dermis
Time Frame: 10 mins
10 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201505100RIND

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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