Clinical trial NCT02506530: Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: lymphedema
breast cancer
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: LPG SYSTEMS
First posted: 2015-07-23
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%)
timeFrame: 6 months
Secondary outcomes:
measure: Progression of the excessive volume in the arm since hospitalization
timeFrame: 6 months
measure: assess adverse effects
timeFrame: 6 months
Other outcomes:
measure: cost effectiveness analysis of treatments
timeFrame: 6 months
Locations:
city: Toulouse
country: France
facility: MALLOIZEL DELAUNAY Julie
state: Midi Pyrenees
Study officials:
affiliation: University Hospital, Toulouse
name: Julie MALLOIZEL-DELAUNAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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. doi: 10.1007/s10549-006-9297-6. Epub 2006 Jul 7.