BREAST CANCER Clinical Trial
Official title:
Lymphedema Prevention in Breast Cancer: a Simple Blind, Randomized, Prospective Clinical Trial of the Efficacy of Physical Therapy
OBJECTIVE: To find out the effectiveness of early application of physical therapy in the
prevention of lymphedema after breast surgery and lymphadenectomy.
DESIGN: Randomized, controlled and single blinded clinical trial. Three years duration.
Patients will be randomly assigned to one of these groups: Experimental group: Early
physical therapy + training in means of prevention; Control group: just training in means of
prevention. In both groups several physical therapy assessments will be undertaken: 1st
before surgery; 2nd immediately after surgery; 3rd after completing intervention; 4th, 5th
and 6th after 3, 6, 12 and 24 months.
SUBJECTS: Women with breast cancer treated with breast surgery including lymphadenectomy in
Principe de Asturias Hospital, provided that there is no contraindication for physical
therapy, and after reading, understanding and freely signing an informed consent form.
SAMPLE SIZE: A total of 116 subjects will be included in the study (58 subjects in each
group), assuming a 15% of drop-outs and at least 20% reduction, with a statistical power of
60%.
DATA ANALYSIS: To find out the effectiveness of intervention we 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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