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Lymphedema Prevention in Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00760123
First Posted: September 26, 2008
Last Update Posted: August 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Torres Lacomba, University of Alcala
  Purpose

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.


Condition Intervention
BREAST CANCER LYMPHEDEMA Other: Early Physical Therapy and Educational strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lymphedema Prevention in Breast Cancer: a Simple Blind, Randomized, Prospective Clinical Trial of the Efficacy of Physical Therapy

Resource links provided by NLM:


Further study details as provided by Maria Torres Lacomba, University of Alcala:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Pain, measured using the Visual Analogue Scale and Shoulder abduction measured using a digital goniometer. [ Time Frame: 2 years ]

Enrollment: 120
Study Start Date: May 2005
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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


  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760123


Locations
Spain
Alcalá University
Alcalá de Henares, Madrid, Spain, 28871
María Torres Lacomba
Alcalá de Henares, Madrid, Spain, 28871
Sponsors and Collaborators
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.
  More Information

Publications:
Responsible Party: Maria Torres Lacomba, PhD, Professor, University of Alcala
ClinicalTrials.gov Identifier: NCT00760123     History of Changes
Other Study ID Numbers: ID1124
First Submitted: September 25, 2008
First Posted: September 26, 2008
Last Update Posted: August 25, 2014
Last Verified: August 2014

Keywords provided by Maria Torres Lacomba, University of Alcala:
Lymphedema
Prevention
Breast cancer
Physical therapy

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases