Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema

Lymphedema Clinical Trial

— ELOCS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506530
• Other study ID #: RC31/14/7425
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Lymphedema

Intervention

Procedure:
• intensive decongestive treatment
intensive decongestive treatment

Device:
• Cellu M6
Use of Cellu M6

Locations

Country	Name	City	State
France	MALLOIZEL DELAUNAY Julie	Toulouse	Midi Pyrenees

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	LPG SYSTEMS

Country where clinical trial is conducted

France, 

References & Publications (4)

Kärki 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2006 Jul 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cost effectiveness analysis of treatments		6 months
Primary	The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)		6 months
Secondary	Progression of the excessive volume in the arm since hospitalization		6 months
Secondary	assess adverse effects		6 months