Breast Cancer Clinical Trial
Official title:
Manual Lymph Drainage in the Prevention of Lymphedema Related to Breast Cancer
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.
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