Lymphedema Prevention in Breast Cancer - Full Text View

Sponsored by:	University of Alcala
Information provided by:	University of Alcala
ClinicalTrials.gov Identifier:	NCT00760123

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

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer Cancer Lymphedema

U.S. FDA Resources

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

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
1: Experimental 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

Arms

Assigned Interventions

1: Experimental

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, Madrid
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:

Stout Gergich NL, Pfalzer LA, McGarvey C, Springer B, Gerber LH, Soballe P. Preoperative assessment enables the early diagnosis and successful treatment of lymphedema. Cancer. 2008 Jun 15;112(12):2809-19.

Responsible Party:	Alcalá University ( María Torres Lacomba )
Study ID Numbers:	ID1124
Study First Received:	September 25, 2008
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00760123
Health Authority:	Spain: Ministry of Health

Keywords provided by University of Alcala:

Lymphedema
Prevention
Breast cancer
Physical therapy

Study placed in the following topic categories:

Lymphedema
Lymphatic Diseases
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009