- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05037708
Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer
Effects of Physiotherapy in the Maintenance Phase in the Treatment of Lymphedema After Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pontevedra, Spain, 36005
- Faculty of Physiotherapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 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 .
|
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 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
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Eva M Lantarón_Caeiro, Dra, Physiotherapy Group (FS1) - Faculty of Physiotherapy -University of Vigo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fisioterapia en Linfedema
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Lymphedema of Upper Limb
-
Lymphatica Medtech SATerminatedLymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema ArmSwitzerland
-
Maastricht University Medical CenterRadboud University Medical Center; Erasmus Medical CenterRecruitingLymphedema of Upper Limb | Lymphedema, Secondary | Lymphedema, Lower Limb | Lymphedema of Leg | Lymphedema ArmNetherlands
-
ThuasneNot yet recruitingLymphedema of Upper LimbTurkey
-
Maastricht University Medical CenterCompleted
-
University of OttawaMcGill University; Horizon Health Network; University of New Brunswick; New Brunswick...UnknownLymphedema of Upper Limb | Mastectomy Related Lymphedema | Lymphedema of Lower Extremity
-
Riphah International UniversityRecruitingLymphedema of Upper LimbPakistan
-
Odense University HospitalDanish Cancer SocietyActive, not recruitingPathologic Processes | Neoplasms | Skin Diseases | Lymphatic Diseases | Postoperative Complications | Breast Cancer | Breast Diseases | Lymphedema | Breast Neoplasm | Surgery | Secondary Lymphedema | Breast Cancer Lymphedema | Lymphedema, Breast Cancer | Lymphedema of Upper Limb | Lymphedema Arm | Iatrogenic Lymphedema | A... and other conditionsDenmark
-
Selcuk UniversityRecruiting
-
Fatih Sultan Mehmet Training and Research HospitalCompleted
-
National Taiwan University HospitalNational Health Research Institutes, TaiwanRecruiting
Clinical Trials on Manual lymphatic drainage
-
Sultan Abdulhamid Han Training and Research Hospital...Istanbul Health Sciences UniversityCompletedVenous Insufficiency | Venous Leg Ulcer | Lymphatic DiseaseTurkey
-
University of FloridaNot yet recruiting
-
Moritz WagnerBezirkskrankenhaus St. Johann in TirolCompletedKnee Osteoarthritis | Rehabilitation | Total Knee Arthroplasty | Manual Lymphatic Drainage | MLDAustria
-
University Hospital, LimogesCompleted
-
Camilo Jose Cela UniversityCompleted
-
University Hospital, GhentCompletedPostoperative Care/Methods | Drainage/Methods | Edema/Prevention & Control | Orthognathic Surgical Procedures/Adverse EffectsBelgium
-
University Hospital, ToursCompletedMaxillofacial Abnormalities | Post Procedural DischargeFrance
-
Anne Arundel Health System Research InstituteTerminated
-
The University of Texas Health Science Center,...HeadStrong FoundationNot yet recruiting
-
Istanbul Medeniyet UniversityCompleted