NCT02506530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 5, 2025

Status Verified

August 1, 2019

Enrollment Period

3.3 years

First QC Date

July 16, 2015

Last Update Submit

November 27, 2025

Conditions

Lymphedema

Keywords

lymphedemabreast cancer

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (2)

  • Progression of the excessive volume in the arm since hospitalization

    6 months

  • assess adverse effects

    6 months

Other Outcomes (1)

  • cost effectiveness analysis of treatments

    6 months

Study Arms (3)

intensive decongestive treatment (IDT)

ACTIVE COMPARATOR

Patients will receive an intensive decongestive treatment for 5 days

Procedure: intensive decongestive treatment

IDT + Cellu M6

EXPERIMENTAL

Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days

Procedure: intensive decongestive treatmentDevice: Cellu M6

Cellu M6 + bandages

ACTIVE COMPARATOR

Patients will receive an bandages + Cellu M6 for 5 days

Device: Cellu M6

Interventions

Cellu M6DEVICE

Use of Cellu M6

Cellu M6 + bandagesIDT + Cellu M6
intensive decongestive treatmentPROCEDURE

intensive decongestive treatment

IDT + Cellu M6intensive decongestive treatment (IDT)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MALLOIZEL DELAUNAY Julie

Toulouse, Midi Pyrenees, 31059, France

Location

Related Publications (2)

  • 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.

    PMID: 31419694RESULT

  • Malloizel-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.

    PMID: 38853038RESULT

MeSH Terms

Conditions

LymphedemaBreast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Julie MALLOIZEL-DELAUNAY, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 23, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 5, 2025

Record last verified: 2019-08

Locations

FR(1)