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Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer

Primary Purpose

Lymphedema of Upper Limb

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual lymphatic drainage
Manual lymphatic drainage
Sponsored by
University of Vigo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphedema of Upper Limb focused on measuring Lymphedema of Upper Limb, Breast Neoplasms, Physical Therapy Modalities

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

circometry
measurement of upper limb perimeters
circometry
measurement of upper limb perimeters
circometry
measurement of upper limb perimeters
circometry
measurement of upper limb perimeters
Volumetry by water displacement
weight of water extravasated when introducing the upper limb into a container with water
Volumetry by water displacement
weight of water extravasated when introducing the upper limb into a container with water
Volumetry by water displacement
weight of water extravasated when introducing the upper limb into a container with water
Volumetry by water displacement
weight of water extravasated when introducing the upper limb into a container with water
Measurement of edema thickness by ultrasound
measurement of subcutaneous tissue thickness
Measurement of edema thickness by ultrasound
measurement of subcutaneous tissue thickness
Measurement of edema thickness by ultrasound
measurement of subcutaneous tissue thickness
Measurement of edema thickness by ultrasound
measurement of subcutaneous tissue thickness

Secondary Outcome Measures

Assessment of the sensation of heaviness
Visual analogic scale
Assessment of the sensation of heaviness
Visual analogic scale
Assessment of the sensation of heaviness
Visual analogic scale
Assessment of the sensation of heaviness
Visual analogic scale
Assessment of the sensation of pain
Visual analogic scale
Assessment of the sensation of pain
Visual analogic scale
Assessment of the sensation of pain
Visual analogic scale
Assessment of the sensation of pain
Visual analogic scale
Assessment of the sensation of tension in the upper limb
Visual analogic scale
Assessment of the sensation of tension in the upper limb
Visual analogic scale
Assessment of the sensation of tension in the upper limb
Visual analogic scale
Assessment of the sensation of tension in the upper limb
Visual analogic scale
dynamometry
Assessment of muscle grip strength by dynamometry
dynamometry
Assessment of muscle grip strength by dynamometry
dynamometry
Assessment of muscle grip strength by dynamometry
dynamometry
Assessment of muscle grip strength by dynamometry

Full Information

First Posted
July 19, 2021
Last Updated
April 4, 2023
Sponsor
University of Vigo
Collaborators
Asociación Gallega de Linfedema
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1. Study Identification

Unique Protocol Identification Number
NCT05037708
Brief Title
Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer
Official Title
Effects of Physiotherapy in the Maintenance Phase in the Treatment of Lymphedema After Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
October 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vigo
Collaborators
Asociación Gallega de Linfedema

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Upper Limb
Keywords
Lymphedema of Upper Limb, Breast Neoplasms, Physical Therapy Modalities

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Procedure
Intervention Name(s)
Manual lymphatic drainage
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Manual lymphatic drainage
Intervention Description
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
Primary Outcome Measure Information:
Title
circometry
Description
measurement of upper limb perimeters
Time Frame
1 day
Title
circometry
Description
measurement of upper limb perimeters
Time Frame
1 month
Title
circometry
Description
measurement of upper limb perimeters
Time Frame
3 month
Title
circometry
Description
measurement of upper limb perimeters
Time Frame
4 month
Title
Volumetry by water displacement
Description
weight of water extravasated when introducing the upper limb into a container with water
Time Frame
1 day
Title
Volumetry by water displacement
Description
weight of water extravasated when introducing the upper limb into a container with water
Time Frame
1 month
Title
Volumetry by water displacement
Description
weight of water extravasated when introducing the upper limb into a container with water
Time Frame
3 month
Title
Volumetry by water displacement
Description
weight of water extravasated when introducing the upper limb into a container with water
Time Frame
4 month
Title
Measurement of edema thickness by ultrasound
Description
measurement of subcutaneous tissue thickness
Time Frame
1 day
Title
Measurement of edema thickness by ultrasound
Description
measurement of subcutaneous tissue thickness
Time Frame
1 month
Title
Measurement of edema thickness by ultrasound
Description
measurement of subcutaneous tissue thickness
Time Frame
3 month
Title
Measurement of edema thickness by ultrasound
Description
measurement of subcutaneous tissue thickness
Time Frame
4 month
Secondary Outcome Measure Information:
Title
Assessment of the sensation of heaviness
Description
Visual analogic scale
Time Frame
1 day
Title
Assessment of the sensation of heaviness
Description
Visual analogic scale
Time Frame
1 month
Title
Assessment of the sensation of heaviness
Description
Visual analogic scale
Time Frame
3 month
Title
Assessment of the sensation of heaviness
Description
Visual analogic scale
Time Frame
4 month
Title
Assessment of the sensation of pain
Description
Visual analogic scale
Time Frame
1 day
Title
Assessment of the sensation of pain
Description
Visual analogic scale
Time Frame
1 month
Title
Assessment of the sensation of pain
Description
Visual analogic scale
Time Frame
3 month
Title
Assessment of the sensation of pain
Description
Visual analogic scale
Time Frame
4 month
Title
Assessment of the sensation of tension in the upper limb
Description
Visual analogic scale
Time Frame
1 day
Title
Assessment of the sensation of tension in the upper limb
Description
Visual analogic scale
Time Frame
1 month
Title
Assessment of the sensation of tension in the upper limb
Description
Visual analogic scale
Time Frame
3 month
Title
Assessment of the sensation of tension in the upper limb
Description
Visual analogic scale
Time Frame
4 month
Title
dynamometry
Description
Assessment of muscle grip strength by dynamometry
Time Frame
1 day
Title
dynamometry
Description
Assessment of muscle grip strength by dynamometry
Time Frame
1 month
Title
dynamometry
Description
Assessment of muscle grip strength by dynamometry
Time Frame
3 month
Title
dynamometry
Description
Assessment of muscle grip strength by dynamometry
Time Frame
4 month

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva M Lantarón_Caeiro, Dra
Organizational Affiliation
Physiotherapy Group (FS1) - Faculty of Physiotherapy -University of Vigo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physiotherapy
City
Pontevedra
ZIP/Postal Code
36005
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer

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