Lymphedema Prevention in Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer; Lymphedema
• Interventions: Procedure: 14 sessions of manual lymphatic drainage technique; Other: the health education

• Registration Number: NCT04112966
• Lead Sponsor: University of Castilla-La Mancha

Brief Summary

OBJECTIVE: To find out the effectiveness of early application of Manual Lymph Drainage in the prevention of upper limb lymphedema after breast surgery and axillary lymphadenectomy in women with breast cancer.

DESIGN: Randomized, controlled and single blinded clinical trial. Five years duration. Patients were randomly assigned to one of these groups: Experimental group: Manual Lymph Drainage + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments were undertaken: 1st before surgery; 2nd 3 month after surgery; 4th, 5th, 6th, 7th, 8th and 9th after 6, 12, 24, 36, 48 and 60 months.

SUBJECTS: Women with breast cancer treated with breast surgery including axillary lymphadenectomy in Provincial Hospital of Toledo, provided that there is no contraindication for manual lymph drainage, and after reading, understanding and freely signing an informed consent form.

SAMPLE SIZE: A total of 150 subjects were included in the study (57 subjects in experimental group and 93 in control group), assuming a 20% of drop-outs and at least 25% reduction, with a statistical power of 75%.

DATA ANALYSIS: To find out the effectiveness of intervention the investigators 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: 2004-05
• Primary Completion: 2011-10
• Study Completion: 2016-10
• Study First Submitted: 2019-07-22
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-01
• Last Update Submitted: 2019-10-01
• Study First Posted: 2019-10-02
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Clinical diagnosis of breast cancer.
• Undergoing unilateral surgery with axillary lymph-node dissection.

Exclusion Criteria

• Bilateral breast cancer.
• Systemic disease.
• Locoregional recurrence.
• Any contraindication to physical therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Manual Lymph Drainage	14 sessions of manual lymphatic drainage technique	14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema.
Early Manual Lymph Drainage	the health education	14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema.
Health education for lymphedema prevention	the health education	Only the health education for lymphedema prevention.

Primary Outcome Measures

Name	Time	Method
Circumference measurements	60 months	Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization and then post-operatively on 60 months after surgery.

Trial Locations

Locations (1)

Provincial Hospital; 🇪🇸 Toledo, Spain