LymphedemaELOCSNCT02506530
Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
A study testing intensive decongestive treatment and Cellu M6 in people with Lymphedema, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- intensive decongestive treatment and Cellu M6
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Dec 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from a lymphoedema consequence of a breast cancer of grades 2 or 3 (ISL)
- Patients suffering from Lymphoedema for 6 months or more
- Patients with a difference between arms >10%
- Patients who had ever had an axillary node dissection
- Patients hospitalized for intensive standard treatment.
Who cannot join
- Primary lymphoedema
- Venous insufficiency of the upper members
- severe arterial obstruction
- obliterating arteritis of the upper limbs
- Bilateral lymphoedema
- Breast cancer recurrence
Show all 19Show fewer
- Another cancer in treatment
- Decompensated heart failure
- Pacemaker
- acute infection
- Deep venous thrombosis
- Skin atrophy of the upper member
- Bullous dermatosis
- Acute dermatitis with epidermitis or dermatitis-hypodermitis
- Infected wound
- Inflammatory scar or consequence of a recent surgery (<1 month)
- Presence of osteosynthesis equipment under the skin with an external part in the upper member to treat
- Hyperalgesia of the shoulder
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of an Endermologie LPG Cellu M6 Treatment in the Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema, During an Intensive Decongestive Treatment.
This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.
Read the detailed description
The main objective of the study is to assess the proportion of successfully treated patients (success rate).
That is to say patients having a reduction of excess arm volume ≥ 30% after 5 days of three types of treatment for secondary lymphoedema :
Group 1: standard intensive decongestive therapy for 5 days (bandages + manual lymphatic drainage).
Group 2: standard intensive decongestive therapy (bandages + manual lymphatic drainage) + Cellu M6 for 5 days Group 3: Bandages + Cellu M6 for 5 days
Symptomatic treatment of lymphoedema reference is intensive decongestive therapy including manual lymphatic drainage, compression of multicomponent bandaging, therapeutic exercise and skin care (HAS 2012 ISL International Society of Lymphology, 2013).
- Conditions
- Lymphedema
- Being tested
- intensive decongestive treatment, Cellu M6
- Keywords
- lymphedema, breast cancer
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive decongestive treatmentProcedure or surgery
intensive decongestive treatment
Cellu M6Device
Use of Cellu M6
| Study group | Role | What they receive |
|---|---|---|
| intensive decongestive treatment (IDT) | Active comparator | Patients will receive an intensive decongestive treatment for 5 days Receives: Procedure: intensive decongestive treatment |
| IDT + Cellu M6 | Experimental | Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days Receives: Procedure: intensive decongestive treatment; Device: Cellu M6 |
| Cellu M6 + bandages | Active comparator | Patients will receive an bandages + Cellu M6 for 5 days Receives: Device: Cellu M6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)
Measured: 6 months
Secondary outcomes (2)
Progression of the excessive volume in the arm since hospitalization
Measured: 6 months
assess adverse effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- LPG SYSTEMS
- Responsible party
- Sponsor
- Investigators
- Julie MALLOIZEL-DELAUNAY, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506530
- Sponsor's protocol ID
- RC31/14/7425
- Acronym
- ELOCS
- Status last verified
- May 2026
- First submitted
- 16 Jul 2015
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Malloizel-Delaunay J, Chantalat E, Bongard V, Chaput B, Garmy-Susini B, Yannoutsos A, Vaysse C. Endermology treatment for breast cancer related lymphedema (ELOCS): Protocol for a phase II randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:35-41. doi: 10.1016/j.ejogrb.2019.07.040. Epub 2019 Aug 7.
PubMed 31419694Malloizel-Delaunay J, Weyl A, Brusq C, Chaput B, Garmy-Susini B, Bongard V, Vaysse C. New Strategy for Breast Cancer Related Lymphedema Treatment by Endermology: ELOCS Phase II Randomized Controlled Trial. Clin Breast Cancer. 2024 Aug;24(6):533-540. doi: 10.1016/j.clbc.2024.05.009. Epub 2024 May 22.
PubMed 38853038
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of an Endermologie LPG Cellu M6 Treatment in the Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema, During an Intensive Decongestive Treatment.
- ClinicalTrials.gov ID
- NCT02506530
- Acronym / sponsor ID
- ELOCS / RC31/14/7425
- Conditions
- Lymphedema
- Keywords
- lymphedema, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- LPG SYSTEMS
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Jul 2015 (estimated)
- 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.
This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.
Detailed description
The main objective of the study is to assess the proportion of successfully treated patients (success rate).
That is to say patients having a reduction of excess arm volume ≥ 30% after 5 days of three types of treatment for secondary lymphoedema :
Group 1: standard intensive decongestive therapy for 5 days (bandages + manual lymphatic drainage).
Group 2: standard intensive decongestive therapy (bandages + manual lymphatic drainage) + Cellu M6 for 5 days Group 3: Bandages + Cellu M6 for 5 days
Symptomatic treatment of lymphoedema reference is intensive decongestive therapy including manual lymphatic drainage, compression of multicomponent bandaging, therapeutic exercise and skin care (HAS 2012 ISL International Society of Lymphology, 2013).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intensive decongestive treatment (IDT) | Active comparator | Procedure: intensive decongestive treatmentPatients will receive an intensive decongestive treatment for 5 days |
| IDT + Cellu M6 | Experimental | Procedure: intensive decongestive treatment, Device: Cellu M6Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days |
| Cellu M6 + bandages | Active comparator | Device: Cellu M6Patients will receive an bandages + Cellu M6 for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from a lymphoedema consequence of a breast cancer of grades 2 or 3 (ISL)
- Patients suffering from Lymphoedema for 6 months or more
- Patients with a difference between arms >10%
- Patients who had ever had an axillary node dissection
- Patients hospitalized for intensive standard treatment.
Key exclusion criteria (19 listed)
- Primary lymphoedema
- Venous insufficiency of the upper members
- severe arterial obstruction
- obliterating arteritis of the upper limbs
- Bilateral lymphoedema
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 |
|---|---|---|
| intensive decongestive treatmentintensive decongestive treatment | Procedure or surgery | IDT + Cellu M6, intensive decongestive treatment (IDT) |
| Cellu M6Use of Cellu M6 | Device | Cellu M6 + bandages, IDT + Cellu M6 |
Primary outcome
The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)
Time frame: 6 months
2 secondary outcomes
Progression of the excessive volume in the arm since hospitalization
Time frame: 6 months
assess adverse effects
Time frame: 6 months
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 1 Jun 2026.
- Results publication: PubMed 31419694Malloizel-Delaunay J, Chantalat E, Bongard V, Chaput B, Garmy-Susini B, Yannoutsos A, Vaysse C. Endermology treatment for breast cancer related lymphedema (ELOCS): Protocol for a phase II randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:35-41. doi: 10.1016/j.ejogrb.2019.07.040. Epub 2019 Aug 7.
- Results publication: PubMed 38853038Malloizel-Delaunay J, Weyl A, Brusq C, Chaput B, Garmy-Susini B, Bongard V, Vaysse C. New Strategy for Breast Cancer Related Lymphedema Treatment by Endermology: ELOCS Phase II Randomized Controlled Trial. Clin Breast Cancer. 2024 Aug;24(6):533-540. doi: 10.1016/j.clbc.2024.05.009. Epub 2024 May 22.
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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.
Julie MALLOIZEL-DELAUNAY, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive decongestive treatment and Cellu M6 in people with Lymphedema, run by University Hospital, Toulouse at 1 site in France.
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 5 inclusion and 19 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 1 Jun 2026. 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 France. 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?
The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506530, which also lists 2 linked publications.
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 1 Jun 2026.