The Effect of Manual Lymph Drainage in the Treatment of Breast Edema

Lead sponsor

Acibadem University is the lead sponsor of 210 studies on the registry; 50 are open to participants now.

Study arms

• Active comparator
  Education, compression and exercise therapy

  Patients will be given exercise therapy every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do home exercise at home for 10 minutes.

  Other: Education, compression and exercise therapy

• Active comparator
  Education, compression,exercise therapy and manual lymph drainage

  Patients will be given manual lymph drainage for one and a half hours every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do self manual lymph drainage at home for 10 minutes.

  Other: Education, compression and exercise therapy manual lymph drainage

Interventions

• OtherEducation, compression and exercise therapy

  Education; It includes information about the disease, information about risk factors, information that one should pay attention to, and skin care. For compression, sponge-shaped pads that create compression into the bra and prepared by the lymphedema physiotherapist will be used. The exercises will include breathing and upper extremity joint movement exercises determined by Casley-Smith, and the other days to be applied by the physiotherapist when the patient comes to the session will be applied by the patient once a day at home.

• OtherEducation, compression and exercise therapy manual lymph drainage

  Education; It includes information about the disease, information about risk factors, information that one should pay attention to, and skin care. For compression, sponge-shaped pads that create compression into the bra and prepared by the lymphedema physiotherapist will be used. The exercises will include breathing and upper extremity joint movement exercises determined by Casley-Smith, and the other days to be applied by the physiotherapist when the patient comes to the session will be applied by the patient once a day at home. In addition, patients will be given manual lymph drainage for one and a half hours every day for the first two weeks. Afterwards, patients will be taken to the same therapy in the hospital for 1 day a week, and on other days they will do self manual lymph drainage at home for 10 minutes.

Primary outcomes

1. LENT-SOMA criteria in breast edema

   Breast Cancer Conservative treatment core objective measurement. It has a score between 13-52 points. As the score increases, it is seen that breast edema worsens. A decrease in the score indicates improvement in breast edema.

   Time frame: Change from baseline LENT-SOMA criteria at 12 weeks

2. Breast edema questionnaire

   Getting 8.5 points from the questionnaire is the cut-off point. There is no breast edema below 8.5, there is breast edema above 8.5. It has a score between 0-80 points.

   Time frame: Change from baseline breast edema questionnaire at 12 weeks

3. Clinical features of breast cancer and breast edema

   The presence of breast fibrosis or edema, teleangiectasia or dyspigmentation will be scored on a 4-point categorical scale. The scale will be in the range of 0-16 points, high scores will indicate worsening of breast edema, and low scores will indicate improvement.

   Time frame: Change from baseline clinical features of breast cancer and breast edema at 12 weeks

4. Qualitiy of Life - European Organization for Research and Treatment of Cancer EORTC- BR23

   The EORTC-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.All scores will linearly transforme to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. More severe symptoms or problems are represented by high symptom scores or items.

   Time frame: Change from baseline Quality of life (EORTC- BR23) test at 12 weeks

Secondary outcomes

1. Breast pain intensity will be measured with the Visual Analog Scale

   The scale is 10 cm long and is applied by specifying a point on the vertical or horizontal line with two different ends (0 = no pain, 10 = the most severe pain) corresponding to the severity of pain felt by the patient.

   Time frame: Change from baseline Visual Analog Scale test at 12 weeks

2. Quality of life test (EORTC QOL-C30)

   It includes 30 items that are grouped into five scales functional (physical, social, emotional functioning, cognitive and role), three scales of symptoms (fatigue, pain, nausea and vomiting), a global scale of health / quality of life and a number of related individual items with the symptoms of the disease and its treatment, as well as an item of economic impact. The answers to the items on the scales refer to "last week," except the patient's physical functioning scale whose time frame is the present. These answers they obey a Likert format, which ranges from 1 ("Not at all") and 4 ("A lot")

   Time frame: Change from baseline Quality of life test (EORTC QOL-C30) at 12 weeks

Individual participant data

Plan to share: Undecided