Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema (ELOCS)

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Procedure: intensive decongestive treatment; Device: Cellu M6

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 Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Midi Pyrenees
    • Toulouse, Midi Pyrenees, France, 31059
      • MALLOIZEL DELAUNAY Julie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: intensive decongestive treatment (IDT); Patients will receive an intensive decongestive treatment for 5 days	Procedure: intensive decongestive treatment; intensive decongestive treatment
EXPERIMENTAL: IDT + Cellu M6; Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days	Procedure: intensive decongestive treatment; intensive decongestive treatment; Device: Cellu M6; Use of Cellu M6
ACTIVE_COMPARATOR: Cellu M6 + bandages; Patients will receive an bandages + Cellu M6 for 5 days	Device: Cellu M6; Use of Cellu M6

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
cost effectiveness analysis of treatments	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: LPG SYSTEMS

Publications and helpful links

General Publications

• Lawenda BD, Mondry TE, Johnstone PA. Lymphedema: a primer on the identification and management of a chronic condition in oncologic treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):8-24. doi: 10.3322/caac.20001.
• Karki A, Anttila H, Tasmuth T, Rautakorpi UM. Lymphoedema therapy in breast cancer patients: a systematic review on effectiveness and a survey of current practices and costs in Finland. Acta Oncol. 2009;48(6):850-9. doi: 10.1080/02841860902755251.
• Mayrovitz HN. The standard of care for lymphedema: current concepts and physiological considerations. Lymphat Res Biol. 2009;7(2):101-8. doi: 10.1089/lrb.2009.0006.
• Vignes S, Porcher R, Arrault M, Dupuy A. Long-term management of breast cancer-related lymphedema after intensive decongestive physiotherapy. Breast Cancer Res Treat. 2007 Mar;101(3):285-90. doi: 10.1007/s10549-006-9297-6. Epub 2006 Jul 7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (ESTIMATE): July 23, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: breast cancer; lymphedema
• Additional Relevant MeSH Terms: Pathologic Processes; Lymphatic Diseases; Postoperative Complications; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: RC31/14/7425