Lymphedema Prevention in Breast Cancer

October 1, 2019 updated by: University of Castilla-La Mancha

Manual Lymph Drainage in the Prevention of Lymphedema Related to Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Toledo, Spain, 45006
        • Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early Manual Lymph Drainage
14 sessions of manual lymphatic drainage technique in the three months following surgery and received health education on the prevention of lymphedema.
Procedure: 14 sessions of manual lymphatic drainage technique
Early manual lymph drainage including 14 sessions of manual lymphatic drainage technique in the three months following surgery and health education for lymphedema prevention including verbal instructions and written materials.
Other: the health education
The health education for lymphedema prevention.
OTHER: Health education for lymphedema prevention
Only the health education for lymphedema prevention.
Other: the health education
The health education for lymphedema prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circumference measurements
Time Frame: 0 months
Circumference measurements of the upper limbs using at 5 cm intervals from the elbow fold preoperatively prior to randomization.
0 months
Circumference measurements
Time Frame: 3 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 3 months after surgery.
3 months
Circumference measurements
Time Frame: 6 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 6 months after surgery.
6 months
Circumference measurements
Time Frame: 12 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 12 months after surgery.
12 months
Circumference measurements
Time Frame: 24 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 24 months after surgery.
24 months
Circumference measurements
Time Frame: 36 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 36 months after surgery.
36 months
Circumference measurements
Time Frame: 48 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 48 months after surgery.
48 months
Circumference measurements
Time Frame: 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.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Collaborators

Castilla-La Mancha Health Service

Investigators

  • Principal Investigator: Helena Romay Barrero, Prof. PhD., University of Castilla-La Mancha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2004

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (ACTUAL)

October 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECA-DLM-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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