Lymphedema Prevention in Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Lymphedema Prevention in Breast Cancer: a Simple Blind, Randomized, Prospective Clinical Trial of the Efficacy of Physical Therapy

Conditions
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BREAST CANCER, LYMPHEDEMA

Intervention / Treatment
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* Other: Early Physical Therapy and Educational strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive women diagnosed with breast cancer and undergoing unilateral surgery with axillary lymph-node dissection at the Príncipe de Asturias Hospital in Alcalá de Henares, Madrid (Spain) are candidates for inclusion in the study. Exclusion Criteria: Patients without axillary lymph-node dissection or with bilateral BC, systemic disease, locoregional recurrence, or any contraindication to physical therapy are excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Early Physical Therapy including a manual lymph-drainage technique, progressive massage of the scar, and progressive active and action-assisted shoulder exercises started in conjunction with functional activities and proprioceptive neuromuscular facilitation without resistance and educational strategy including instruction with printed materials about the lymphatic system, concepts of normal load versus overload, lymphedema source, the identification of possible precipitating factors, etc. | Other: Early Physical Therapy and Educational strategy<br>* Experimental group: physical therapy including a manual lymph-drainage technique, progressive massage of the scar, and progressive active and action-assisted shoulder exercises started in conjunction with functional activities and proprioceptive neuromuscular facilitation without resistance and Educational strategy including instruction with printed materials about the lymphatic system, concepts of normal load versus overload, lymphedema source, the identification of possible precipitating factors,etc. Other: control group: only the educational strategy<br>|
| Other: 2<br>Educational Strategy: instruction with printed materials about the lymphatic system, concepts of normal load versus overload, lymphedema source, the identification of possible precipitating factors, etc. | Other: Early Physical Therapy and Educational strategy<br>* Experimental group: physical therapy including a manual lymph-drainage technique, progressive massage of the scar, and progressive active and action-assisted shoulder exercises started in conjunction with functional activities and proprioceptive neuromuscular facilitation without resistance and Educational strategy including instruction with printed materials about the lymphatic system, concepts of normal load versus overload, lymphedema source, the identification of possible precipitating factors,etc. Other: control group: only the educational strategy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on hospital discharge (between Day 3 and Day 5), 4 weeks, and 3, 6, 12 and 24 months after surgery. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, measured using the Visual Analogue Scale and Shoulder abduction measured using a digital goniometer. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema, Prevention, Breast cancer, Physical therapy