Lymphedema of Upper LimbNCT05037708
Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer
A study testing Manual lymphatic drainage in people with Lymphedema of Upper Limb, run by University of Vigo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Lymphedema of Upper Limb
- What is being tested?
- Manual lymphatic drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 27 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women included in the lymphedema treatment maintenance program through the Galician Lymphedema Association
- Women with secondary unilateral lymphedema after breast cancer
Who cannot join
- Women undergoing chemotherapy or radiotherapy treatment.
- Severe systemic or neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphedema of Upper Limb
- Being tested
- Manual lymphatic drainage
- Keywords
- Lymphedema of Upper Limb, Breast Neoplasms, Physical Therapy Modalities
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual lymphatic drainageProcedure or surgery
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
Manual lymphatic drainageProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Procedure: Manual lymphatic drainage |
| Group 2 | Active comparator | 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 . Receives: Procedure: Manual lymphatic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
circometry
measurement of upper limb perimeters
Measured: 1 day
circometry
measurement of upper limb perimeters
Measured: 1 month
circometry
measurement of upper limb perimeters
Measured: 3 month
circometry
measurement of upper limb perimeters
Measured: 4 month
Volumetry by water displacement
weight of water extravasated when introducing the upper limb into a container with water
Measured: 1 day
Volumetry by water displacement
weight of water extravasated when introducing the upper limb into a container with water
Measured: 1 month
Volumetry by water displacement
weight of water extravasated when introducing the upper limb into a container with water
Measured: 3 month
Volumetry by water displacement
weight of water extravasated when introducing the upper limb into a container with water
Measured: 4 month
Measurement of edema thickness by ultrasound
measurement of subcutaneous tissue thickness
Measured: 1 day
Measurement of edema thickness by ultrasound
measurement of subcutaneous tissue thickness
Measured: 1 month
Measurement of edema thickness by ultrasound
measurement of subcutaneous tissue thickness
Measured: 3 month
Measurement of edema thickness by ultrasound
measurement of subcutaneous tissue thickness
Measured: 4 month
Secondary outcomes (16)
Assessment of the sensation of heaviness
Visual analogic scale
Measured: 1 day
Assessment of the sensation of heaviness
Visual analogic scale
Measured: 1 month
Assessment of the sensation of heaviness
Visual analogic scale
Measured: 3 month
Assessment of the sensation of heaviness
Visual analogic scale
Measured: 4 month
Assessment of the sensation of pain
Visual analogic scale
Measured: 1 day
Assessment of the sensation of pain
Visual analogic scale
Measured: 1 month
Assessment of the sensation of pain
Visual analogic scale
Measured: 3 month
Assessment of the sensation of pain
Visual analogic scale
Measured: 4 month
Assessment of the sensation of tension in the upper limb
Visual analogic scale
Measured: 1 day
Assessment of the sensation of tension in the upper limb
Visual analogic scale
Measured: 1 month
Assessment of the sensation of tension in the upper limb
Visual analogic scale
Measured: 3 month
Assessment of the sensation of tension in the upper limb
Visual analogic scale
Measured: 4 month
dynamometry
Assessment of muscle grip strength by dynamometry
Measured: 1 day
dynamometry
Assessment of muscle grip strength by dynamometry
Measured: 1 month
dynamometry
Assessment of muscle grip strength by dynamometry
Measured: 3 month
dynamometry
Assessment of muscle grip strength by dynamometry
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Mar 2022
- Primary completion1 Jul 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of Upper LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Gallega de Linfedema
- Responsible party
- Principal investigator, Eva María Lantarón Caeiro, University of Vigo
- Investigators
- Eva M Lantarón_Caeiro, Dra, Principal investigator, Physiotherapy Group (FS1) - Faculty of Physiotherapy -University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037708
- Sponsor's protocol ID
- Fisioterapia en Linfedema
- Status last verified
- Apr 2023
- First submitted
- 19 Jul 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physiotherapy in the Maintenance Phase in the Treatment of Lymphedema After Breast Cancer
- ClinicalTrials.gov ID
- NCT05037708
- Acronym / sponsor ID
- Fisioterapia en Linfedema
- Conditions
- Lymphedema of Upper Limb
- Keywords
- Lymphedema of Upper Limb, Breast Neoplasms, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Collaborators
- Asociación Gallega de Linfedema
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Manual lymphatic drainageGroup 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 | Active comparator | Procedure: Manual lymphatic drainageGroup 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 . |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women included in the lymphedema treatment maintenance program through the Galician Lymphedema Association
- Women with secondary unilateral lymphedema after breast cancer
Key exclusion criteria (2 listed)
- Women undergoing chemotherapy or radiotherapy treatment.
- Severe systemic or neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual lymphatic drainageSubjects 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 or surgery | Group 1 |
| Manual lymphatic drainageSubjects 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 | Procedure or surgery | Group 2 |
Primary outcome
circometry
Time frame: 1 day
measurement of upper limb perimeters
circometry
Time frame: 1 month
measurement of upper limb perimeters
circometry
Time frame: 3 month
measurement of upper limb perimeters
circometry
Time frame: 4 month
measurement of upper limb perimeters
Volumetry by water displacement
Time frame: 1 day
weight of water extravasated when introducing the upper limb into a container with water
Volumetry by water displacement
Time frame: 1 month
weight of water extravasated when introducing the upper limb into a container with water
Volumetry by water displacement
Time frame: 3 month
weight of water extravasated when introducing the upper limb into a container with water
Volumetry by water displacement
Time frame: 4 month
weight of water extravasated when introducing the upper limb into a container with water
Measurement of edema thickness by ultrasound
Time frame: 1 day
measurement of subcutaneous tissue thickness
Measurement of edema thickness by ultrasound
Time frame: 1 month
measurement of subcutaneous tissue thickness
Measurement of edema thickness by ultrasound
Time frame: 3 month
measurement of subcutaneous tissue thickness
Measurement of edema thickness by ultrasound
Time frame: 4 month
measurement of subcutaneous tissue thickness
16 secondary outcomes
Assessment of the sensation of heaviness
Time frame: 1 day
Assessment of the sensation of heaviness
Time frame: 1 month
Assessment of the sensation of heaviness
Time frame: 3 month
Assessment of the sensation of heaviness
Time frame: 4 month
Assessment of the sensation of pain
Time frame: 1 day
Assessment of the sensation of pain
Time frame: 1 month
Assessment of the sensation of pain
Time frame: 3 month
Assessment of the sensation of pain
Time frame: 4 month
Assessment of the sensation of tension in the upper limb
Time frame: 1 day
Assessment of the sensation of tension in the upper limb
Time frame: 1 month
Assessment of the sensation of tension in the upper limb
Time frame: 3 month
Assessment of the sensation of tension in the upper limb
Time frame: 4 month
dynamometry
Time frame: 1 day
dynamometry
Time frame: 1 month
dynamometry
Time frame: 3 month
dynamometry
Time frame: 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Lymphedema of Upper Limb
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Recruiting
Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva M Lantarón_Caeiro, Dra principal investigator
Physiotherapy Group (FS1) - Faculty of Physiotherapy -University of Vigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual lymphatic drainage in people with Lymphedema of Upper Limb, run by University of Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circometry (time frame: 1 day). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.