Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema

Cairo University (CU)

Status: Completed

Conditions: Mastectomy; Lymphedema

Treatments: Device: Negative pressure therapy; Device: Endermologie

Study type: Interventional

Funder types: Other

Identifiers

NCT05761353

P.T.REC/012/003744

Details and patient eligibility

About

Statement of the problem:

The problem will be stated in a questionary form:

"Which will be more effective endermologie or negative pressure therapy in reducing limb circumference and volume in postmastectomy lymphedema?".

Hypothesis:

It will be hypothesized that:

There is no significant difference between endermologie and negative pressure therapy in reducing circumference and limb volume in post mastectomy lymphedema.

Full description

Subject:

Sixty- eight women treated for unilateral breast cancer with secondary upper limb lymphedema post mastectomy will participate in this study. Their ages will be ranged from 40 to 60 years, they will be free from any other diseases that will affect or influence the results and the participants will be selected from National Cancer Institute and randomly distributed into two equal groups in number.

Study design:

In this study the patients will be randomly assigned into two groups equal in number (34 patients for each group).

Inclusion Criteria:

The subject selection will be according to the following criteria:

• Only females will participate in the study.
• Patients' age will be ranged between 40-60 years.
• All patients will suffer from post mastectomy lymph-edema.
• All patients have a modified radical mastectomy.
• All patients will suffer from grade II lymph edema without skin changes one year post mastectomy.
• All patients are right-dominant hand.
• All patients enrolled to the study have their informed consent.

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

• primary lymph-edema.
• Diabetes mellitus.
• Pregnancy.
• Recurrent cancer.
• Current or recent cellulitis.
• Current metastases.
• Venous thrombosis.
• Photosensitivity.
• Phlebitis in development stage.
• Infection.
• Receiving anti-coagulant treatment.

Equipment:

The study equipment's will be divided into measurement and therapeutic equipment and tools:

1: Measurement equipment

1(a):Limb volume measurement:

This will be performed by measuring the circumference of each segment of the limb between two consecutive circumferences as a truncated zone. The volume of the segment was calculated as:

V=h (c12+c1c2+c22 )/12π, where V is the volume of the segment, c1 and c2 are the circumferences at the ends of the segment, and h is the distance between them.

Measurement of limb volume measurement will be conducted pre-treatment and after treatment course (6 weeks).

1. (b): Measuring Disability of the arm, shoulder and hand by: .Quick DASH questionnaire (Disability of the arm, shoulder, and hand).

   • The Quick- DASH has five response options for each item from 0=no difficulty to perform or no symptoms to 5=unable to do.
   • Quick DASH scale will be conducted pre-treatment and after treatment course (6 weeks).

2. Therapeutic equipment :

3. a. Endermologie: endermologie therapy will be three sessions per week for six weeks (total 18 sessions).

The study group will receive 18 sessions by Endermologie system ( used to decrease postmastectomy lymphedema for group (A), three sessions per week for six weeks.

Each session was 30 minutes at the posterior thorax, upper arm, forearm and the hand.

2.b. Negative pressure therapy:

• Pressure: 20-250 mm Hg.
• Total treatment period: six weeks.
• A number of sessions: 3 sessions/ week. Time of application : 30 min

Enrollment: 68 patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Only females will participate in the study.
• Patients' age was ranged between 40-60 years.
• All patients will suffer from post mastectomy lymphedema.
• All patients have a modified radical mastectomy.
• All patients suffer from grade II lymphedema without skin changes one year post mastectomy(as defined by the International Society of Lymphology).
• All patients are right-dominant hand.
• All patients enrolled to the study will have their informed consent.

Exclusion criteria

• The potential participants will be excluded if they meet one of the following criteria:

  • primary lymphedema.
  • Diabetes mellitus.
  • Pregnancy.
  • Recurrent cancer.
  • Current or recent cellulitis.
  • Current metastases.
  • Venous thrombosis.
  • Photosensitivity.
  • Phlebitis in development stage.
  • Infection.
  • Receiving anti-coagulant treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

68 participants in 2 patient groups

Group A (endermologie group)

Experimental group

Description:

This group includes 34 patients who will receive 30 min Endermologie 3 times per week in addition to their physical therapy program (active range of motion and elevation); hygiene and skin care for 6 weeks.

Treatment:

Device: Endermologie

Group B (Negative pressure therapy group)

Experimental group

Description:

This group includes34 patients who will receive 30min negative pressure therapy 3 times per week in addition to their physical therapy program (active range of motion and elevation); hygiene and skin care for 6 weeks

Treatment:

Device: Negative pressure therapy