Lymphedema Prevention in Breast Cancer

Not Applicable

Completed

• Conditions: BREAST CANCER; LYMPHEDEMA

• Registration Number: NCT00760123
• Lead Sponsor: University of Alcala

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

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-22
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	2 years

Secondary Outcome Measures

Name	Time	Method
Pain, measured using the Visual Analogue Scale and Shoulder abduction measured using a digital goniometer.	2 years

Trial Locations

Locations (2)

Alcalá University; 🇪🇸 Alcalá de Henares, Madrid, Spain

María Torres Lacomba; 🇪🇸 Alcalá de Henares, Madrid, Spain