Lymphedema Prevention After Lymph Node Emptying
Condition: Lymphedema; Breast Cancer; Prevention; Rehabilitation
MeSH terms: Breast Neoplasms; Lymphedema
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Exercices; Informative talk; Compression garment
Intervention type(s): Behavioral; Behavioral; Device
Intervention description(s): 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.; 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention