Lymphedema Prevention in Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of Alcala.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Alcala
ClinicalTrials.gov Identifier:
NCT00760123
First received: September 25, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain, measured using the Visual Analogue Scale and Shoulder abduction measured using a digital goniometer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2005
Estimated Study Completion Date: December 2009
Estimated 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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760123

Contacts
Contact: María Torres Lacomba, Prof. 0034918854841 maria.torres@uah.es
Contact: Marijo Yuste Sánchez, Prof. marijo.yuste@uah.es

Locations
Spain
Alcalá University Recruiting
Alcalá de Henares, Madrid, Spain, 28871
Principal Investigator: María Torres Lacomba, Prof.         
María Torres Lacomba Recruiting
Alcalá de Henares, Madrid, Spain, 28871
Principal Investigator: María Torres Lacomba, Prof.         
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: María Torres Lacomba, Alcalá University
ClinicalTrials.gov Identifier: NCT00760123     History of Changes
Other Study ID Numbers: ID1124
Study First Received: September 25, 2008
Last Updated: September 25, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on April 22, 2014