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Completed

NCT Number: NCT02506530

Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema

This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

MALLOIZEL DELAUNAY Julie

Toulouse, Midi Pyrenees, 31059, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intensive decongestive treatment

Procedure

intensive decongestive treatment

Cellu M6

Device

Use of Cellu M6

Primary outcomes

  1. The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)

    Time frame: 6 months

Secondary outcomes

  1. Progression of the excessive volume in the arm since hospitalization

    Time frame: 6 months

  2. assess adverse effects

    Time frame: 6 months

Other outcomes

  1. cost effectiveness analysis of treatments

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • LPG SYSTEMS

Registry information

Official study 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.

Acronym: ELOCS

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2015
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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