Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer

April 4, 2023 updated by: Eva María Lantarón Caeiro, University of Vigo

Effects of Physiotherapy in the Maintenance Phase in the Treatment of Lymphedema After Breast Cancer

Lymphedema related to breast cancer is one of the main complications after breast cancer treatment. Manual lymphatic drainage appears as a technique which could be applied in the treatment of lymphedema along with other techniques. The aim of this study is to analyze the effects of a physiotherapy program based on manual lymphatic drainage on the treatment of lymphedema after breast cancer, during the stabilization or maintenance phase of complex decongestant therapy. Therefore, a randomized, blinded, crossover clinical trial is suggested to assess the effect of an intensive physiotherapy intervention on the treatment of lymphedema in its maintenance phase, in comparison with a control group without physiotherapy treatment. The cytometry, displaced water volume, thickness of the lymphedema with ultrasound, dynamometry and sensation of heaviness, pain and tension of the upper limb will be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Complex decongestant therapy is a set of techniques which seek the treatment of lymphedema in a conservative way as described in the recent international consensus of the International Lymphology Society, published in 2020. Complex decongestant therapy in a first phase aims to reduce cutaneous edema and in a second phase it aims to preserve and optimize the results obtained.

The first phase consists of skin care, manual lymphatic drainage, muscle pumping exercises, and compression techniques, typically applied with multilayer bandages. The second phase consists of compression with low elasticity, skin care exercises, and repeated manual lymphatic drainage as needed.

The frequency and intensity of components of complex decongestant therapy in phase I and II should depend on the clinical findings of edema and the stage of lymphedema and could be adapted to clinical changes. Note that phase II or stabilization represents long-term therapy over many years and in the case of deterioration of edema, phase I of complex decongestant therapy may need to be repeated.

In recent years, there is debate about the efficacy of manual lymphatic drainage. Sometimes it is not prescribed, being replaced by the recommendation of a self-massage. Furthermore, complex decongestant therapy was suggested to be time consuming, expensive and difficult to tolerate, and does not improve lymphatic function.

In contrast, researchers such as Müller et al., in 2018, state that it is a well-tolerated and safe treatment technique, demonstrating benefits in reducing edema. Other research has also shown that manual lymphatic drainage is effective both on a preventive level and as a postoperative rehabilitation treatment, having optimal results when combined with the other elements of complex decongestant therapy.

A recent systematic review published in 2020 highlights the need of more experimental studies on the effectiveness of manual lymphatic drainage on lymphedema. Thus, the

purpose of this study is to analyze the effects of a physiotherapy program based on manual lymphatic drainage in the treatment of lymphedema after breast cancer, during the stabilization or maintenance phase of complex decongestant therapy. Therefore, a double-blind crossover clinical trial is proposed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Pontevedra, Spain, 36005
        • Faculty of Physiotherapy

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women included in the lymphedema treatment maintenance program through the Galician Lymphedema Association
  • Women with secondary unilateral lymphedema after breast cancer

Exclusion Criteria:

  • Women undergoing chemotherapy or radiotherapy treatment.
  • Severe systemic or neurological disease

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Group 1 receives treatment A for 4 weeks. Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment B was applied to group 1.
Procedure: Manual lymphatic drainage

Subjects are randomly assigned to group 1. Group 1 receives treatment A* for 4 weeks.

Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment B** was applied to group 1 for 4 weeks.

*Treatment A consists of manual lymphatic drainage.

**Treatment B consists of no treatment

Procedure: Manual lymphatic drainage

Subjects are randomly assigned to group 2. Group 2 receives treatment B** for 4 weeks.

Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment A* was applied to group 2 for 4 weeks.

*Treatment A consists of manual lymphatic drainage.

**Treatment B consists of no treatment
Active Comparator: Group 2
Group 2 receives treatment B for 4 weeks. Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment A was applied to group 2 .
Procedure: Manual lymphatic drainage

Subjects are randomly assigned to group 1. Group 1 receives treatment A* for 4 weeks.

Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment B** was applied to group 1 for 4 weeks.

*Treatment A consists of manual lymphatic drainage.

**Treatment B consists of no treatment

Procedure: Manual lymphatic drainage

Subjects are randomly assigned to group 2. Group 2 receives treatment B** for 4 weeks.

Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment A* was applied to group 2 for 4 weeks.

*Treatment A consists of manual lymphatic drainage.

**Treatment B consists of no treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
circometry
Time Frame: 1 day
measurement of upper limb perimeters
1 day
circometry
Time Frame: 1 month
measurement of upper limb perimeters
1 month
circometry
Time Frame: 3 month
measurement of upper limb perimeters
3 month
circometry
Time Frame: 4 month
measurement of upper limb perimeters
4 month
Volumetry by water displacement
Time Frame: 1 day
weight of water extravasated when introducing the upper limb into a container with water
1 day
Volumetry by water displacement
Time Frame: 1 month
weight of water extravasated when introducing the upper limb into a container with water
1 month
Volumetry by water displacement
Time Frame: 3 month
weight of water extravasated when introducing the upper limb into a container with water
3 month
Volumetry by water displacement
Time Frame: 4 month
weight of water extravasated when introducing the upper limb into a container with water
4 month
Measurement of edema thickness by ultrasound
Time Frame: 1 day
measurement of subcutaneous tissue thickness
1 day
Measurement of edema thickness by ultrasound
Time Frame: 1 month
measurement of subcutaneous tissue thickness
1 month
Measurement of edema thickness by ultrasound
Time Frame: 3 month
measurement of subcutaneous tissue thickness
3 month
Measurement of edema thickness by ultrasound
Time Frame: 4 month
measurement of subcutaneous tissue thickness
4 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of the sensation of heaviness
Time Frame: 1 day
Visual analogic scale
1 day
Assessment of the sensation of heaviness
Time Frame: 1 month
Visual analogic scale
1 month
Assessment of the sensation of heaviness
Time Frame: 3 month
Visual analogic scale
3 month
Assessment of the sensation of heaviness
Time Frame: 4 month
Visual analogic scale
4 month
Assessment of the sensation of pain
Time Frame: 1 day
Visual analogic scale
1 day
Assessment of the sensation of pain
Time Frame: 1 month
Visual analogic scale
1 month
Assessment of the sensation of pain
Time Frame: 3 month
Visual analogic scale
3 month
Assessment of the sensation of pain
Time Frame: 4 month
Visual analogic scale
4 month
Assessment of the sensation of tension in the upper limb
Time Frame: 1 day
Visual analogic scale
1 day
Assessment of the sensation of tension in the upper limb
Time Frame: 1 month
Visual analogic scale
1 month
Assessment of the sensation of tension in the upper limb
Time Frame: 3 month
Visual analogic scale
3 month
Assessment of the sensation of tension in the upper limb
Time Frame: 4 month
Visual analogic scale
4 month
dynamometry
Time Frame: 1 day
Assessment of muscle grip strength by dynamometry
1 day
dynamometry
Time Frame: 1 month
Assessment of muscle grip strength by dynamometry
1 month
dynamometry
Time Frame: 3 month
Assessment of muscle grip strength by dynamometry
3 month
dynamometry
Time Frame: 4 month
Assessment of muscle grip strength by dynamometry
4 month

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Vigo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Asociación Gallega de Linfedema

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eva M Lantarón_Caeiro, Dra, Physiotherapy Group (FS1) - Faculty of Physiotherapy -University of Vigo

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Fisioterapia en Linfedema

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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