Lymphedema Prevention in Breast Cancer

August 22, 2014 updated by: Maria Torres Lacomba, University of Alcala

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28871
        • Alcalá University
      • Alcalá de Henares, Madrid, Spain, 28871
        • María Torres Lacomba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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

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
Other: 2
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Investigators

  • Principal Investigator: María Torres Lacomba, Prof., Alcalá University
  • Study Chair: Maria José Yuste Sánchez, Prof., Alcalá University
  • Study Chair: Álvaro Zapico Goñi, MD, Principe de Asturias Hospital University
  • Study Chair: David Prieto Merino, Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, UK
  • Study Chair: Orlando Mayoral del Moral, Prof., Provincial Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (Estimate)

September 26, 2008

Study Record Updates

Last Update Posted (Estimate)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID1124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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