Lymphedema Prevention After Lymph Node Emptying

March 4, 2021 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Effectiveness of Lymphedema Prevention Programs After Lymph Node Emptying in Breast Cancer: A Randomized Clinical Trial

ABSTRACT Object: The impact of morbidity and the deterioration in health-related quality of life for patients with lymphedema after axillary lymph node dissection for breast cancer justify the implementation of prevention programs to decrease the incidence of this chronic condition. The aim was to compare the effectiveness of an experimental prevention program with that of our conventional prevention program.

Methods: Clinical randomized trial in two parallel groups over a two-year period.

Key words: lymphedema, breast cancer, prevention, rehabilitation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a single-centre, open-label, controlled, randomized clinical trial. Patients were recruited from the Breast Pathology Unit at Hospital de la Santa Creu i Sant Pau (HSCSP), a tertiary referral hospital in Barcelona between March 2011 and April 2013. The inclusion criteria were as follows:

  • Patients between 18 and 85 years
  • Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
  • Acceptance of the study conditions and signing of the informed consent

Exclusion criteria were:

  • tumour recurrences
  • metastatic cancer
  • open wounds or loss of skin integrity
  • dependency or deterioration of higher functions
  • arterial insufficiency and deep vein thrombosis
  • acute heart failure
  • severe peripheral neuropathy
  • lymphedema Patients included in the study were randomized to one of two groups. Group 1(G1) carried out the conventional prevention program consisting of an informative talk and an exercise program. Group 2(G2) carried out the same program but with the addition of a prophylactic compression garment.

The program common to both groups consisted of:

  1. An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center (J.González-Sánchez y Sánchez- Mata F 2010) (See tables 1 and 2).
  2. An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.

Group 2 (experimental) was also prescribed:

• A flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night. From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity.

The study was evaluated and authorized by the Ethics Committee at Hospital de la Santa Creu i Sant Pau (HSCSP), code IIBS-EPC-2011-87. All patients signed the written informed consent form.

Evaluations All patients were evaluated at the start of the study, at the end of the exercise prevention program, at 6 months, and at one and two years.

In all the evaluations, we measured the volume of the upper extremities following the lymphedema calculation formula based on the truncated cone, validated and published by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF).

Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs (SERMEF 2012).

We recorded all the parameters of the history and general clinical examination, TNM stage, performed treatments, number of resected nodes and complications. Compliance with all the components of each program was monitored. Data regarding presence at the talk and at the exercise program sessions at the centre were recorded by calendar. Home compliance was monitored through personal interviews at 6 months, 1 year and 2 years.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

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:

  • Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
  • Acceptance of the study conditions and signing of the informed consent

Exclusion Criteria:

  • Tumour recurrences
  • Metastatic cancer
  • Open wounds or loss of skin integrity
  • Dependency or deterioration of higher functions
  • Arterial insufficiency and deep vein thrombosis
  • Acute heart failure
  • Severe peripheral neuropathy
  • Lymphedema

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group EC1: Exercices, informative talk
Group EC1 carried out the conventional prevention program consisting of an informative talk and an exercise program
Behavioral: Exercices
An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.
Behavioral: Informative talk
An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center
Experimental: Group ECCP2: Exercices, informative talk, compression garment
Group ECCP2 carried out the same program but with the addition of a prophylactic compression garment
Behavioral: Exercices
An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.
Behavioral: Informative talk
An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center
Device: Compression garment

Wearing a flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night.

From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of arms volume
Time Frame: All patients were evaluated at the start of the study
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs (SERMEF 2012).
All patients were evaluated at the start of the study
Measure of arms volume
Time Frame: All patients were evaluated at 3 months from beginning
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs
All patients were evaluated at 3 months from beginning

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of arms volume
Time Frame: All patients were evaluated at 6 months from beginning
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs
All patients were evaluated at 6 months from beginning
Measure of arms volume
Time Frame: All patients were evaluated at 12 months from beginning
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs
All patients were evaluated at 12 months from beginning
Measure of arms volume
Time Frame: All patients were evaluated at 24 months from beginning
Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs
All patients were evaluated at 24 months from beginning

Collaborators and Investigators

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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

  • Principal Investigator: Maria José Nadal Castells, PhD, Hospital de La Santa Creu Y Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 3, 2011

Primary Completion (Actual)

October 3, 2011

Study Completion (Actual)

April 13, 2015

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-EPC-2011-87

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We recorded all the parameters of the history and general clinical examination, TNM stage, performed treatments, number of resected nodes and complications. Compliance with all the components of each program was monitored. Data regarding presence at the talk and at the exercise program sessions at the centre were recorded by calendar. Home compliance was monitored through personal interviews at 6 months, 1 year and 2 years.

IPD Sharing Time Frame

Supporting information is already available

IPD Sharing Access Criteria

Free access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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