Mastectomy; LymphedemaNCT05761353
Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema
A study testing Endermologie and Negative pressure therapy in people with Mastectomy; Lymphedema, run by Cairo University at 1 site in Egypt.
Trial 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?". Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mastectomy; Lymphedema
- What is being tested?
- Endermologie and Negative pressure therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jun 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Current metastases.
- Venous thrombosis.
- Photosensitivity.
- Phlebitis in development stage.
- Infection.
- Receiving anti-coagulant treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Cairo university
Giza, Dokki, 11432
About this study
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.
Read the 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).
- (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).
- Therapeutic equipment :
- 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
- Conditions
- Mastectomy; Lymphedema
- Being tested
- Endermologie, Negative pressure therapy
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndermologieDevice
Group A 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.
-In addition to physical therapy program (active range of motion and elevation); hygiene and skin care
Negative pressure therapyDevice
Group B will receive negative pressure therapy with
- Pressure: 20-250 mmHg.
- Total treatment period: 6weeks
- A number of sessions: 3sessions/ week. Time of application : 30 min
- In addition to physical therapy program (active range of motion and elevation); hygiene and skin care
| Study group | Role | What they receive |
|---|---|---|
| Group A (endermologie group) | Experimental | 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. Receives: Device: Endermologie |
| Group B (Negative pressure therapy group) | Experimental | 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 Receives: Device: Negative pressure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Disability of the arm, shoulder and hand
Measuring Disability of the arm, shoulder and hand will be carried out by using Quick-DASH questionnaire
Measured: Measuring will be taken before treatment and after 6 weeks of treatment to monitor the change in upper limb function before and after treatment
Limb volume measurement
Limb volume measurement will be carried out by 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 (c1+c1c2+c2 )/12π
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start29 Jun 2022
- Primary completion1 Jun 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy; LymphedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rayda Maher Mohamed Abdelkhalek, Cairo University
- Investigators
- Rayda M Mohamed, Principal investigator, Cairo Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761353
- Sponsor's protocol ID
- P.T.REC/012/003744
- Status last verified
- Dec 2023
- First submitted
- 13 Feb 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endermologie Versus Negative Pressure Therapy on Postmastectomy Lymphedema
- ClinicalTrials.gov ID
- NCT05761353
- Acronym / sponsor ID
- P.T.REC/012/003744
- Conditions
- Mastectomy; Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- (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).
- Therapeutic equipment :
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (endermologie group) | Experimental | Device: EndermologieThis 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. |
| Group B (Negative pressure therapy group) | Experimental | Device: Negative pressure therapyThis 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (12 listed)
- The potential participants will be excluded if they meet one of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndermologieGroup A 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. -In addition to physical therapy program (active range of motion and elevation); hygiene and skin care | Device | Group A (endermologie group) |
| Negative pressure therapyGroup B will receive negative pressure therapy with * Pressure: 20-250 mmHg. * Total treatment period: 6weeks * A number of sessions: 3sessions/ week. Time of application : 30 min * In addition to physical therapy program (active range of motion and elevation); hygiene and skin care | Device | Group B (Negative pressure therapy group) |
Primary outcome
Measuring Disability of the arm, shoulder and hand
Time frame: Measuring will be taken before treatment and after 6 weeks of treatment to monitor the change in upper limb function before and after treatment
Measuring Disability of the arm, shoulder and hand will be carried out by using Quick-DASH questionnaire
Limb volume measurement
Time frame: 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
Limb volume measurement will be carried out by 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 (c1+c1c2+c2 )/12π
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rayda M Mohamed principal investigator
Cairo Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endermologie and Negative pressure therapy in people with Mastectomy; Lymphedema, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Disability of the arm, shoulder and hand (time frame: Measuring will be taken before treatment and after 6 weeks of treatment to monitor the change in upper limb function before and after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.