Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL

NACompletedINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

March 31, 2020

Study Completion Date

September 30, 2020

Conditions
Breast NeoplasmLymphedema
Interventions
OTHER

Information

During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material

OTHER

Skin care

The skin is hydrated during the session. If wounds are present, the wound is cared.

OTHER

Compression therapy

During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment

OTHER

Fluoroscopy-guided MLD

Fluoroscopy-guided MLD is applied on patient-specific lymphatic system (known from lymphofluoroscopy) by applying cleaning techniques on lymph nodes, resorption techniques to stimulate resorption of lymph by lymph capillaries and gliding technique to stimulate transport of lymph through lymph collectors

OTHER

Traditional MLD

Traditional MLD is applied without knowledge of the patient-specific lymphatic architecture. During MLD no cream or oil is used. A pressure with the hands up to 40 mmHg is applied. Drainage is performed at the level of the jugular and occipital region and the belly (in the depth). Draining techniques are applied on the retroclavicular lymph nodes, axillary lymph nodes, humeral lymph nodes and cubital lymph nodes. At the level of the hand, arm, shoulder and trunk, hand movements are applied to stimulate lymphatic transport through the lymph collectors. The therapist's hands perform 'pumping-movements' while stretching the skin.

OTHER

Placebo MLD

During placebo MLD a superficial massage with massage cream is performed on the patient's contralateral arm and on the belly.

Trial Locations (3)

1000

Centre Hospitalier Universitaire (CHU) Sint-Pieter, Lymphoedema Clinic, Brussels

2650

Antwerp University Hospital, Antwerp

3000

University Hospitals of Leuven, lymphovenous center, Leuven

All Listed Sponsors
collaborator

Agentschap voor Innovatie door Wetenschap en Technologie

OTHER

lead

Universitaire Ziekenhuizen KU Leuven

OTHER

NCT02609724 - Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL | Biotech Hunter | Biotech Hunter