Spots Global Cancer Trial Database for Lymphedema Prevention in Breast Cancer
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Trial Identification
Brief Title: Lymphedema Prevention in Breast Cancer
Official Title: Lymphedema Prevention in Breast Cancer: a Simple Blind, Randomized, Prospective Clinical Trial of the Efficacy of Physical Therapy
Study ID: NCT00760123
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Alcalá University, Alcalá de Henares, Madrid, Spain
María Torres Lacomba, Alcalá de Henares, Madrid, Spain
Contact Details
Name: María Torres Lacomba, Prof.
Affiliation: Alcalá University
Role: PRINCIPAL_INVESTIGATOR
Name: Maria José Yuste Sánchez, Prof.
Affiliation: Alcalá University
Role: STUDY_CHAIR
Name: Álvaro Zapico Goñi, MD
Affiliation: Principe de Asturias Hospital University
Role: STUDY_CHAIR
Name: David Prieto Merino
Affiliation: Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, UK
Role: STUDY_CHAIR
Name: Orlando Mayoral del Moral, Prof.
Affiliation: Provincial Hospital.
Role: STUDY_CHAIR
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