New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)
Condition: Breast Cancer Lymphedema; Post-Mastectomy Secondary Lymphedema
MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Lymphedema; Breast Cancer Lymphedema
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of an experimental proposal therapy for upper limb
      lymphedema secondary to breast called Activity-oriented proprioceptive antiedema therapy
      (TAPA) facing the consensual gold standard treatment, the complete decongestive therapy. TAPA
      consists in:

        -  Health education / patient empowerment.

        -  Neurodynamic activities oriented to Activities of Daily Living (ADL).

        -  Proprioceptive neuromuscular facilitation exercises oriented to ADL.

        -  Self-adherent self-adhesive antiedema of low compression.

      Half of patients will receive TAPA treatment while the other half will receive CDT standard
      treatment.
    

Detailed description: 
      Lymphedema is defined as the abnormal accumulation of tissue proteins, which is accompanied
      of edema and chronic inflammation of a limb, so post-mastectomy lymphedema is one of the most
      serious sequelae of Breast Cancer (BC) that affects the quality of life of women operated for
      breast cancer. Its incidence is approximately between 6 and 30% of patients and its
      prevalence varies between 15-20%. It is considered a process without spontaneous resolution
      that involves the application of a palliative therapy conservative for life, with preventive
      measures to reduce it and prevent complications and an expected increase in the number of
      patients with lymphedema in the next years

      Changes in work performance resulting from lymphedema vary from minor temporary changes to
      significant difficulties in the ADL, depending on the chronicity and severity of the
      affectation. It could affect physical components and psychological, as well as social and
      economic environment. In these limitations on activities and / or restrictions of
      participation, the Occupational Therapists (OT) provide a unique approach, since they are
      professionals specifically enabled for the use of the therapeutic potential of the activity
      and graduation of its control parameters in favor of the best occupational performance
      possible of the person. Furthermore, there are some research that support the inclusion of OT
      in the cancer rehabilitation and reveal a significant need for more research to explore ways
      in which the OT favorably influences the results of the cancer survivors.

      The anamnesis, clinical exploration and complementary studies if necessary, allow us confirm
      the diagnosis of lymphedema, stage, possibilities of progression and approach the most
      indicated therapeutic in each case.

      The conservative therapeutic of upper limb lymphoedema secondary to breast cancer plan
      includes preventive exercises and lifestyle habits, complete decongestive therapy (CDT) and
      compression garments.

      The CDT comprises a series of measures, a first intensive phase consists of:

        -  Skin care.

        -  Kinesitherapy

        -  Manual lymphatic drainage (MLD)

        -  Multilayer bandage. The maintenance phase is based on self-care and the use of
           compression garments.

      Despite the consensus of the experts in the evidence of decongestive therapy in lymphedema,
      there is still a lack of evidence to inform the optimal doses of treatment and the level of
      evidence about its efficacy in the treatment of lymphedema is only moderately strong, due to
      the scarcity of randomized trials with control group, well interventions controlled, accurate
      measures of volume, mobility or function and quality of life.

      Likewise, the prescription of compression garments for lymphoedema is very varied and it may
      be due to the lack of underlying evidence to inform about the treatment. The evidence also
      suggests that the comprehensiveness and effectiveness of rehabilitation post-operative BC
      should also consider the self-control (empowerment) of patients, approaches to redesign the
      lifestyle and incorporate aspects of the promotion of health.

      On the other hand, there are studies that confirm that women with lymphedema and pain after
      BC may present alterations in neural mechanosensitivity, neuropathic pain, as a result of
      nerve compression or peripheral neuropathy induced by chemotherapy and that it is worth
      conducting a clinical trial to evaluate the techniques of Neural mobilization (NM) oriented
      to the functionality of upper extremities, supporting the clinical mechanism of NM in the
      reduction of intraneural edema.

      Published research suggests incorporating proprioceptive neuromuscular facilitation (PNF)
      with the traditional NM method, to facilitate the process of treatment for patients with
      lymphoedema, because it induces powerful synergistic effects on the volume of edema, range of
      motion (ROM) of the shoulder, pain and depression. That treatment independently or in
      combination with laser also improves these variables and even the speed of blood circulation
      in the armpit. Furthermore, in a study in which bandaging could not be used and CDT was
      combined with PNF and respiration, reducing lymphedema and improving ROM too, which could
      improve performance of activities, level of participation and, therefore, quality of life.

      There are research supporting use of Coban®3M bandage as early start of pressotherapy in the
      rehabilitation treatment of lymphedema to reduce prolonged edema (agent cause of multiple
      complications and functional loss), we consider the possibility of testing the efficacy of a
      bandage with similar characteristics, in terms of elasticity and self-adherence, more
      economical, applying it from distal to proximal, with a low level of compression, in order to
      provide proprioceptive information, but avoiding compressive syndrome, reducing pain and
      edema and improving the performance of ADL through the practice of them. It consists in only
      two thin layers and it is fast (10 minutes) and simple placement (can be self-administered by
      the patient and / or caregiver), improving cost- effectiveness of treatments combined with
      three other techniques whose evidence has been previously reviewed. We have agreed to call
      this therapy we propose in this study Activity-oriented Proprioceptive Antiedema Therapy
      (TAPA in Spanish):

        -  Health education / patient empowerment.

        -  Neurodynamic activities oriented to ADL.

        -  Proprioceptive neuromuscular facilitation exercises oriented to ADL.

        -  Self-adherent self-adhesive antiedema of low compression.

      Given the consensus of the CDT as a gold standard treatment in lymphedema, we consider that
      our experimental treatment TAPA should make the comparison with it. So, half of patients will
      receive TAPA treatment while the other half will receive CDT standard treatment.
    

Intervention name(s): Activity-oriented Proprioceptive Antiedema Therapy (TAPA); Complete Decongestive Therapy (CDT)
Intervention type(s): Other; Other
Intervention description(s): Health education / patient empowerment.
Neurodynamic activities oriented to ADL.
Proprioceptive neuromuscular facilitation exercises oriented to ADL.
Self-adherent self-adhesive antiedema of low compression.; Skin care.
Kinesitherapy
Manual lymphatic drainage (MLD)
Multilayer bandage.
The maintenance phase is based on self-care and the use of compression garments.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After proposing to the subjects the enrollment to the study and once they accept, they will be randomly allocated to experimental TAPA treatment group or standard CDT treatment. They will be assessed 1 to 3 days before and after completing the treatment. It will be consists in a total of 10 sessions of 30 minutes of treatment, twice per week in a total 5 weeks period.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast Cancer; Breast Cancer Lymphedema; Post-Mastectomy Secondary Lymphedema; Occupational Therapy; Proprioceptive Neuromuscular Facilitation; Neural Mobilization