Clinical trial NCT05037708: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema of Upper Limb
Keywords: Lymphedema of Upper Limb
Breast Neoplasms
Physical Therapy Modalities
Lead sponsor: University of Vigo
Sponsor class: OTHER
Collaborators: name: Asociación Gallega de Linfedema
First posted: 2021-09-08
Enrollment: 28
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: circometry
timeFrame: 1 day
measure: circometry
timeFrame: 1 month
measure: circometry
timeFrame: 3 month
measure: circometry
timeFrame: 4 month
measure: Volumetry by water displacement
timeFrame: 1 day
measure: Volumetry by water displacement
timeFrame: 1 month
measure: Volumetry by water displacement
timeFrame: 3 month
measure: Volumetry by water displacement
timeFrame: 4 month
measure: Measurement of edema thickness by ultrasound
timeFrame: 1 day
measure: Measurement of edema thickness by ultrasound
timeFrame: 1 month
measure: Measurement of edema thickness by ultrasound
timeFrame: 3 month
measure: Measurement of edema thickness by ultrasound
timeFrame: 4 month
Secondary outcomes:
measure: Assessment of the sensation of heaviness
timeFrame: 1 day
measure: Assessment of the sensation of heaviness
timeFrame: 1 month
measure: Assessment of the sensation of heaviness
timeFrame: 3 month
measure: Assessment of the sensation of heaviness
timeFrame: 4 month
measure: Assessment of the sensation of pain
timeFrame: 1 day
measure: Assessment of the sensation of pain
timeFrame: 1 month
measure: Assessment of the sensation of pain
timeFrame: 3 month
measure: Assessment of the sensation of pain
timeFrame: 4 month
measure: Assessment of the sensation of tension in the upper limb
timeFrame: 1 day
measure: Assessment of the sensation of tension in the upper limb
timeFrame: 1 month
measure: Assessment of the sensation of tension in the upper limb
timeFrame: 3 month
measure: Assessment of the sensation of tension in the upper limb
timeFrame: 4 month
measure: dynamometry
timeFrame: 1 day
measure: dynamometry
timeFrame: 1 month
measure: dynamometry
timeFrame: 3 month
measure: dynamometry
timeFrame: 4 month
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Faculty of Physiotherapy
Study officials:
affiliation: Physiotherapy Group (FS1) - Faculty of Physiotherapy -University of Vigo
name: Eva M Lantarón_Caeiro, Dra
role: PRINCIPAL_INVESTIGATOR
References: