Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02506530

Acronym

ELOCS

Enrollment

Registered

2015-07-23

Start date

2015-09-01

Completion date

2018-12-01

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Keywords

lymphedema, breast cancer

Brief summary

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).

Interventions

PROCEDUREintensive decongestive treatment

intensive decongestive treatment

DEVICECellu M6

Use of Cellu M6

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Primary lymphoedema * Venous insufficiency of the upper members * severe arterial obstruction * obliterating arteritis of the upper limbs * Bilateral lymphoedema * Breast cancer recurrence * 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.

Design outcomes

Primary

Measure	Time frame
The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)	6 months

Secondary

Measure	Time frame
Progression of the excessive volume in the arm since hospitalization	6 months
assess adverse effects	6 months

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJulie MALLOIZEL-DELAUNAY, MD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026