Lymphedema Prevention in Breast Cancer

University of Castilla-La Mancha

Status: Completed

Conditions: Breast Cancer; Lymphedema

Treatments: Other: the health education; Procedure: 14 sessions of manual lymphatic drainage technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04112966

ECA-DLM-5

Details and patient eligibility

About

OBJECTIVE: To find out the effectiveness of early application of Manual Lymph Drainage in the prevention of upper limb lymphedema after breast surgery and axillary lymphadenectomy in women with breast cancer.

DESIGN: Randomized, controlled and single blinded clinical trial. Five years duration. Patients were randomly assigned to one of these groups: Experimental group: Manual Lymph Drainage + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments were undertaken: 1st before surgery; 2nd 3 month after surgery; 4th, 5th, 6th, 7th, 8th and 9th after 6, 12, 24, 36, 48 and 60 months.

SUBJECTS: Women with breast cancer treated with breast surgery including axillary lymphadenectomy in Provincial Hospital of Toledo, provided that there is no contraindication for manual lymph drainage, and after reading, understanding and freely signing an informed consent form.

SAMPLE SIZE: A total of 150 subjects were included in the study (57 subjects in experimental group and 93 in control group), assuming a 20% of drop-outs and at least 25% reduction, with a statistical power of 75%.

DATA ANALYSIS: To find out the effectiveness of intervention the investigators will compare the rate of lymphedema in both groups by means of a logistic regression analysis, in which the main factor is the intervention group. Other factors aimed to control the effect of the intervention will also be included. In order to compare the rate of appearance of lymphedema in both groups, a survival analysis will also be included.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of breast cancer.
• Undergoing unilateral surgery with axillary lymph-node dissection.

Exclusion criteria

• Bilateral breast cancer.
• Systemic disease.
• Locoregional recurrence.
• Any contraindication to physical therapy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Early Manual Lymph Drainage

Experimental group

Description:

14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema.

Treatment:

Other: the health education

Procedure: 14 sessions of manual lymphatic drainage technique

Health education for lymphedema prevention

Other group

Description:

Only the health education for lymphedema prevention.

Treatment:

Other: the health education