Clinical trial NCT05761353: Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema
Official title: Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastectomy; Lymphedema
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 68
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 :

2. 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

Eligibility criteria: 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.

Primary outcomes:
measure: Measuring Disability of the arm, shoulder and hand
timeFrame: Measuring will be taken before treatment and after 6 weeks of treatment to monitor the change in upper limb function before and after treatment
measure: Limb volume measurement
timeFrame: Measuring will be taken before treatment and after 6 weeks of treatment to monitor the change in upper limb volume and decrease of lymph-edema
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Outpatient clinic, Faculty of Physical Therapy, Cairo university
state: Dokki
Study officials:
affiliation: Cairo Unversity
name: Rayda M Mohamed
role: PRINCIPAL_INVESTIGATOR
References: