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

Toulouse University Hospital

Status: Completed

Conditions: Lymphedema

Treatments: Procedure: intensive decongestive treatment; Device: Cellu M6

Study type: Interventional

Funder types: Other

Identifiers

NCT02506530

RC31/14/7425

Details and patient eligibility

About

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

Full 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).

Enrollment: 93 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

intensive decongestive treatment (IDT)

Active Comparator group

Description:

Patients will receive an intensive decongestive treatment for 5 days

Treatment:

Procedure: intensive decongestive treatment

IDT + Cellu M6

Experimental group

Description:

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

Treatment:

Device: Cellu M6

Procedure: intensive decongestive treatment

Cellu M6 + bandages

Active Comparator group

Description:

Patients will receive an bandages + Cellu M6 for 5 days

Treatment:

Device: Cellu M6