Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL (EFforT-BCRL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609724
Recruitment Status : Unknown
Verified May 2017 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : November 20, 2015
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
The main scientific objective of this multicentric double-blinded randomised controlled trial entails examining the effectiveness of fluoroscopy-guided MLD versus traditional MLD versus placebo MLD, applied as part of the intensive and maintenance phase of Decongestive Lymphatic Therapy, for the treatment of BCRL Secondary scientific objectives entail examining the relationship between different variables of lymphoedema at baseline

Condition or disease Intervention/treatment Phase
Breast Neoplasm Lymphedema Other: Information Other: Skin care Other: Compression therapy Other: Fluoroscopy-guided MLD Other: Traditional MLD Other: Placebo MLD Not Applicable

Detailed Description:

According to the International Society of Lymphology, lymphoedema needs to be treated with Decongestive Lymphatic Therapy (Consensus Document ISL 2013). This is a two-stage treatment programme. During the first or intensive phase, lymphoedema has to be maximally reduced. This phase consists of skin care, manual lymph drainage (MLD), multi-layer bandaging and exercise therapy. The second or maintenance phase aims to conserve and optimise the results obtained in the first phase. It consists of skin care, compression by a low-stretch elastic sleeve, exercises and lymph drainage. Skin care, multi-layer bandaging, elastic sleeve and exercises are treatment modalities that (after instructing the patient) can be performed by the patient herself. MLD has to be applied by a physical therapist and hence entails a big financial cost for the patient and the Health Care (Kärki et al 2009). The effectiveness of MLD applied during the intensive phase has been investigated by 5 randomised controlled trials, but there is conflicting evidence. So, further investigation is warranted to determine the relative benefit of MLD. The effectiveness of MLD applied during the maintenance phase has never been investigated (Devoogdt et al 2010, Oremus et al 2012, Huang et al 2013, Ezzo et al 2015).

A possible explanation why MLD is not obviously proven to be effective, is that MLD is applied in an inefficient way: during MLD, hand manoeuvres are applied on all lymph nodes and lymphatics that may be anatomically present. After axillary dissection and/ or radiotherapy (for the treatment of breast cancer), the lymphatic system is damaged: lymph nodes are removed and often fibrosis of the superficial lymphatic system occurs. As a result, rerouting of the lymphatic drainage occurs. Rerouting is patient-specific, consequently, it is possible that the traditional MLD needs be abandoned and a tailored approach needs to be established. Lymphofluoroscopy can aid to apply a more efficient MLD. During lymphofluoroscopy, a fluorescent substance is injected subcutaneously in the hand and it visualizes the transport of lymph from the hand up to the axilla and it demonstrates alternative pathways towards other lymph nodes.

A second explanation why the traditional method of MLD is not proven to be effective, is that research has shown that MLD with high pressure (vs low pressure) is more effective to improve lymph transport, as well as gliding (vs no gliding). During the new method of MLD (or fluoroscopy-guided MLD), the therapist only performs hand movements on functional lymphatics and lymph nodes. In addition, the hand movements are applied with higher pressure and lymph transport through the lymph collaterals is stimulated by applying strikes across the skin.

Therefore, the main scientific objective entails examining the effectiveness of fluoroscopy-guided MLD versus traditional MLD versus placebo MLD, applied as part of the intensive and maintenance phase of Decongestive Lymphatic Therapy, for the treatment of BCRL

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Fluoroscopy-guided Manual Lymph Drainage (MLD) Versus Traditional MLD or Placebo MLD, as Part of Decongestive Lymphatic Therapy, for the Treatment of Breast Cancer-related Lymphoedema (BCRL): a Randomised Controlled Trial
Actual Study Start Date : January 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: Fluoroscopy-guided MLD
Information, skin care, compression therapy, exercises and fluoroscopy-guided MLD 3 weeks (15 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment
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

Active Comparator: Traditional MLD
Information, skin care, compression therapy, exercises and traditional MLD 3 weeks (15 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment
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: 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.

Placebo Comparator: Placebo MLD
Information, skin care, compression therapy, exercises and placebo MLD 3 weeks (15 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment
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: Placebo MLD
During placebo MLD a superficial massage with massage cream is performed on the patient's contralateral arm and on the belly.




Primary Outcome Measures :
  1. Change of lymphoedema volume of arm/ hand [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]
  2. Change of stagnation of fluid at level of shoulder/ trunk [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]

Secondary Outcome Measures :
  1. Change of extracellular fluid in arm [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]
  2. Change of thickness and reflectivity of cutis and subcutis of arm/ shoulder/ trunk [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]
  3. Change of problems in functioning related to development of breast cancer-related lymphoedema [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]
  4. Change of elasticity of skin and subcutaneous tissue of arm [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]
  5. Change of lymphatic architecture and function [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]
  6. Change of venous circulation in arm/ trunk [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]
  7. Change of quality of life [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]
  8. Number of episodes of erysipelas [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]
  9. Number of responders to the treatment [ Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18y (since the treatment with MLD and the investigation using ICG is not dangerous for pregnant women, women with child bearing age are included)
  • Women/ men with breast cancer-related lymphoedema
  • Chronic lymphoedema (>3 months present), stage I to IIb
  • At least 5% difference between both arms and/ or hands, adjusted for dominance
  • Written informed consent obtained

Exclusion Criteria:

  • Allergy for iodine, sodiumiodine, ICG
  • Increased activity of the thyroid gland; benign tumors of the thyroid gland
  • Age <18y
  • Oedema of the upper limb from other causes
  • Active metastasis of the cancer
  • Surgery of the lymphatic system in the past (lymph node transplantation, lymphovenous shunt)
  • Cannot participate during the entire study period
  • Mentally or physically unable to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609724


Contacts
Layout table for location contacts
Contact: Nele Devoogdt, PhD 0032 16 342515 nele.devoogdt@uzleuven.be
Contact: Nick Gebruers, PhD 0032 496 184346 nick.gebruers@uantwerpen.be

Locations
Layout table for location information
Belgium
Antwerp University Hospital Recruiting
Antwerp, Belgium, 2650
Contact: Wiebren Tjalma, PhD    0032 3 8215904    wiebren.tjalma@uza.be   
Contact: Nick Gebruers, PhD    0032 496 184346    nick.gebruers@uantwerpen.be   
Centre Hospitalier Universitaire (CHU) Sint-Pieter, Lymphoedema Clinic Recruiting
Brussel, Belgium, 1000
Contact: Liesbeth Vandermeeren, MD    0032 2 5353762    liesbethvandermeeren@hotmail.com   
Contact: Jean-Paul Belgrado, PT    0033 6 38397956    belgrado@ulb.ac.be   
University Hospitals of Leuven, lymphovenous center Recruiting
Leuven, Belgium, 3000
Contact: Nele Devoogdt, PhD    0032 16 342515    nele.devoogdt@uzleuven.be   
Contact: Sarah Thomis, MD    0032 16 346948    sarah.thomis@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Layout table for investigator information
Principal Investigator: Nele Devoogdt, PhD University of Leuven - KU Leuven and University Hospitals Leuven

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02609724    
Other Study ID Numbers: IWT150178
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitaire Ziekenhuizen Leuven:
breast cancer
lymphedema
manual lymph drainage
near infrared fluorescence imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases