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

National Taiwan University

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: manual lymph drainage; Other: epidermis fascia taping; Other: self massage

Study type: Interventional

Funder types: Other

Identifiers

NCT02707835

201505100RIND

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

5. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

control group

Active Comparator group

Description:

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

Treatment:

Other: self massage

manual lymph drainage group

Active Comparator group

Description:

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

Treatment:

Other: manual lymph drainage

experimental group

Experimental group

Description:

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

Treatment:

Other: epidermis fascia taping