Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Procedure: intensive decongestive treatment; Device: Cellu M6

• Registration Number: NCT02506530
• Lead Sponsor: University Hospital, Toulouse

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).

Study Timeline

• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-23
• Study Start: 2015-09
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intensive decongestive treatment (IDT)	intensive decongestive treatment	Patients will receive an intensive decongestive treatment for 5 days
Cellu M6 + bandages	Cellu M6	Patients will receive an bandages + Cellu M6 for 5 days
IDT + Cellu M6	Cellu M6	Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days
IDT + Cellu M6	intensive decongestive treatment	Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
assess adverse effects	6 months
Progression of the excessive volume in the arm since hospitalization	6 months

Trial Locations

Locations (1)

MALLOIZEL DELAUNAY Julie; 🇫🇷 Toulouse, Midi Pyrenees, France