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It was done a four week phase with Kinesio Taping in the arm affected with lymphedema.

It was done a four week phase with Compression garment in the arm affected with lymphedema.

Kinesio Taping

Compression Garment

Violeta Pajero Otero, MRes

Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence backs it. The aim of this study is to compare the reduction of lymphedema volume with both therapies.

Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG.

Research design:

Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . The initial sample was selected among the patients of "Breast Pathology Rehabilitation" at Hospital Universitario 12 de Octubre . The planned sample size was 30.

Cross Design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability.

Open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, CG or KT, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. However, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. Statistical study was also made by others (staff of the "Clinique Investigation Unit (i+12)" of Hospital Universitario 12 de Octubre) with coded variables to blind the analyst.

Two treatmet phases, with a four week wash out period bewtween them:

* A four week phase with Kinesio Taping
* A four week phase with compression garments.

The statistical analysis will be supervised by staff of the Scientific Support Unit: Epidemiology and Biostatistics (i+12), Hospital Universitario 12 de Octubre with the variables coded to blind the analyst.

Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema

Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.

Goniometry of shoulder, elbow, wrist and hand.

Hospital Universitario 12 de Octubre

University of Castilla-La Mancha

Violeta Pajero Otero

Physiotherapist at the Mammary Pathology Unit

Group EC1 carried out the conventional prevention program consisting of an informative talk and an exercise program

Group ECCP2 carried out the same program but with the addition of a prophylactic compression garment

An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.

Exercices

An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center

Informative talk

Wearing a flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night.

From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity.

Compression garment

Maria José Nadal Castells, PhD

ABSTRACT Object: The impact of morbidity and the deterioration in health-related quality of life for patients with lymphedema after axillary lymph node dissection for breast cancer justify the implementation of prevention programs to decrease the incidence of this chronic condition. The aim was to compare the effectiveness of an experimental prevention program with that of our conventional prevention program.

Methods: Clinical randomized trial in two parallel groups over a two-year period.

Key words: lymphedema, breast cancer, prevention, rehabilitation

This was a single-centre, open-label, controlled, randomized clinical trial. Patients were recruited from the Breast Pathology Unit at Hospital de la Santa Creu i Sant Pau (HSCSP), a tertiary referral hospital in Barcelona between March 2011 and April 2013. The inclusion criteria were as follows:

* Patients between 18 and 85 years
* Having undergone a lymph node dissection as part of treatment for primary breast neoplasm
* Acceptance of the study conditions and signing of the informed consent

Exclusion criteria were:

* tumour recurrences
* metastatic cancer
* open wounds or loss of skin integrity
* dependency or deterioration of higher functions
* arterial insufficiency and deep vein thrombosis
* acute heart failure
* severe peripheral neuropathy
* lymphedema Patients included in the study were randomized to one of two groups. Group 1(G1) carried out the conventional prevention program consisting of an informative talk and an exercise program. Group 2(G2) carried out the same program but with the addition of a prophylactic compression garment.

The program common to both groups consisted of:

1. An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center (J.González-Sánchez y Sánchez- Mata F 2010) (See tables 1 and 2).
2. An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.

Group 2 (experimental) was also prescribed:

• A flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night. From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity.

The study was evaluated and authorized by the Ethics Committee at Hospital de la Santa Creu i Sant Pau (HSCSP), code IIBS-EPC-2011-87. All patients signed the written informed consent form.

Evaluations All patients were evaluated at the start of the study, at the end of the exercise prevention program, at 6 months, and at one and two years.

In all the evaluations, we measured the volume of the upper extremities following the lymphedema calculation formula based on the truncated cone, validated and published by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF).

Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs (SERMEF 2012).

We recorded all the parameters of the history and general clinical examination, TNM stage, performed treatments, number of resected nodes and complications. Compliance with all the components of each program was monitored. Data regarding presence at the talk and at the exercise program sessions at the centre were recorded by calendar. Home compliance was monitored through personal interviews at 6 months, 1 year and 2 years.

Lymphedema Prevention After Lymph Node Emptying

Effectiveness of Lymphedema Prevention Programs After Lymph Node Emptying in Breast Cancer: A Randomized Clinical Trial

We recorded all the parameters of the history and general clinical examination, TNM stage, performed treatments, number of resected nodes and complications. Compliance with all the components of each program was monitored. Data regarding presence at the talk and at the exercise program sessions at the centre were recorded by calendar. Home compliance was monitored through personal interviews at 6 months, 1 year and 2 years.

Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs

Lymphedema was defined as a difference of more than 200 ml in volume between the upper extremities, or as a difference of 10% in volume between the two upper limbs (SERMEF 2012).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema	NCT03051776	Breast Cancer L...	Kinesio Taping Compression Gar...	18 Years -	Hospital Universitario 12 de Octubre
Lymphedema Prevention After Lymph Node Emptying	NCT04785599	Lymphedema Breast Cancer Prevention Rehabilitation	Exercices Informative tal... Compression gar...	18 Years - 85 Years	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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