Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-12-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intensive decongestive treatment (IDT)

Patients will receive an intensive decongestive treatment for 5 days

Group Type ACTIVE_COMPARATOR

intensive decongestive treatment

Intervention Type PROCEDURE

intensive decongestive treatment

IDT + Cellu M6

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

Group Type EXPERIMENTAL

intensive decongestive treatment

Intervention Type PROCEDURE

intensive decongestive treatment

Cellu M6

Intervention Type DEVICE

Use of Cellu M6

Cellu M6 + bandages

Patients will receive an bandages + Cellu M6 for 5 days

Group Type ACTIVE_COMPARATOR

Cellu M6

Intervention Type DEVICE

Use of Cellu M6

Interventions

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intensive decongestive treatment

Intervention Type PROCEDURE

Cellu M6

Use of Cellu M6

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No