Breast Cancer, Lymphedema
Conditions
Keywords
Lymphedema, Prevention
Brief summary
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.
Interventions
PROCEDURE14 sessions of manual lymphatic drainage technique
Early manual lymph drainage including 14 sessions of manual lymphatic drainage technique in the three months following surgery and health education for lymphedema prevention including verbal instructions and written materials.
OTHERthe health education
The health education for lymphedema prevention.
Sponsors
Castilla-La Mancha Health Service
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circumference measurements | 0 months | Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization. |
Countries
Spain
Outcome results
None listed