Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL

NCT02609724 | Completed Results

• 1 other identifier: IWT150178
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 3

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

Conditions

Breast Neoplasm; Lymphedema

Keywords

breast cancer; lymphedema; manual lymph drainage; near infrared fluorescence imaging

Outcome Measures

Primary Outcomes (2)

• Lymphoedema Volume at the Level of the Arm/ Hand

  = the ratio at the different time points; The (inter-limb) ratio = Relative excessive lymphoedema volume of the arm/ hand = \[(volume arm + volume hand affected side) / (corrected volume arm + corrected volume hand healthy side)\]; Volume arm is determined by performing circumference measurements and calculating the volume with the formula of the truncated cone; Volume hand is determined by the water displacement method; The volume of the non-dominant hand/arm is on average 3.3% smaller than the dominant hand/arm, therefore is the volume of the arm at the healthy side corrected for hand dominance

  Primary endpoint = After 3 weeks of intensive treatment

• Stagnation of Fluid at Level of the Shoulder/ Trunk

  Ratio PWC% at the different time intervals = PWC% affected side / PWC% healthy side Measured with the MoistureMeterD compact at the level of shoulder and trunk where after a mean ratio PWC% is calculated

  Primary endpoint = After 3 weeks of intensive treatment

Secondary Outcomes (12)

• Extracellular Fluid in the Upper Limb

  After 3 weeks of intensive treatment, 1, 3, 6 months of maintenance treatment and 6 months of follow-up

• Thickness of Cutis and Subcutis of Arm and Trunk Measured With Ultrasound

  After 3 weeks of intensive treatment and 6 months of maintenance treatment and 6 months of follow-up

• Problems in Functioning Related to Development of Breast Cancer-related Lymphoedema

  After 3 weeks of intensive treatment, 1, 3, 6 months of maintenance treatment and 6 months of follow-up

• Elasticity of Skin and Subcutaneous Tissue of Arm and Trunk Using the SkinFibrometer

  After 3 weeks of intensive treatment, 1, 3, 6 months of maintenance treatment and 6 months of follow-up

• Quality of Life Score

  After 3 weeks of intensive treatment and 1, 3, 6 months of maintenance treatment and 6 months of follow-up

Study Arms (3)

Fluoroscopy-guided MLD

EXPERIMENTAL

Information, skin care, compression therapy, exercises and fluoroscopy-guided MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up

Other: Information; Other: Skin care; Other: Compression therapy; Other: Fluoroscopy-guided MLD

Traditional MLD

ACTIVE COMPARATOR

Information, skin care, compression therapy, exercises and traditional MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up

Other: Information; Other: Skin care; Other: Compression therapy; Other: Traditional MLD

Placebo MLD

PLACEBO COMPARATOR

Information, skin care, compression therapy, exercises and placebo MLD 3 weeks (14 sessions of 60 minutes) of intensive treatment 6 months (18 sessions of 60 minutes) of maintenance treatment 6 months of follow-up

Other: Information; Other: Skin care; Other: Compression therapy; Other: Placebo MLD

Interventions

Information OTHER

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

Fluoroscopy-guided MLD; Placebo MLD; Traditional MLD

Skin care OTHER

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

Fluoroscopy-guided MLD; Placebo MLD; Traditional MLD

Compression therapy OTHER

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

Fluoroscopy-guided MLD; Placebo MLD; Traditional MLD

Fluoroscopy-guided MLD OTHER

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

Fluoroscopy-guided MLD

Traditional MLD OTHER

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.

Traditional MLD

Placebo MLD OTHER

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

Placebo MLD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

Study Sites (3)

Antwerp University Hospital

Antwerp, 2650, Belgium

Location

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

Brussels, 1000, Belgium

Location

University Hospitals of Leuven, lymphovenous center

Leuven, 3000, Belgium

Location

Related Publications (19)

• Huang TW, Tseng SH, Lin CC, Bai CH, Chen CS, Hung CS, Wu CH, Tam KW. Effects of manual lymphatic drainage on breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. World J Surg Oncol. 2013 Jan 24;11:15. doi: 10.1186/1477-7819-11-15.

  PMID: 23347817 BACKGROUND

• Ezzo J, Manheimer E, McNeely ML, Howell DM, Weiss R, Johansson KI, Bao T, Bily L, Tuppo CM, Williams AF, Karadibak D. Manual lymphatic drainage for lymphedema following breast cancer treatment. Cochrane Database Syst Rev. 2015 May 21;2015(5):CD003475. doi: 10.1002/14651858.CD003475.pub2.

  PMID: 25994425 BACKGROUND

• Devoogdt N, Christiaens MR, Geraerts I, Truijen S, Smeets A, Leunen K, Neven P, Van Kampen M. Effect of manual lymph drainage in addition to guidelines and exercise therapy on arm lymphoedema related to breast cancer: randomised controlled trial. BMJ. 2011 Sep 1;343:d5326. doi: 10.1136/bmj.d5326.

  PMID: 21885537 BACKGROUND

• Devoogdt N, Van Kampen M, Geraerts I, Coremans T, Christiaens MR. Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity. Phys Ther. 2011 Jun;91(6):944-57. doi: 10.2522/ptj.20100087. Epub 2011 Apr 14.

  PMID: 21493748 BACKGROUND

• Devoogdt N, Lemkens H, Geraerts I, Van Nuland I, Flour M, Coremans T, Christiaens MR, Van Kampen M. A new device to measure upper limb circumferences: validity and reliability. Int Angiol. 2010 Oct;29(5):401-7.

  PMID: 20924341 BACKGROUND

• Devoogdt N, Pans S, De Groef A, Geraerts I, Christiaens MR, Neven P, Vergote I, Van Kampen M. Postoperative evolution of thickness and echogenicity of cutis and subcutis of patients with and without breast cancer-related lymphedema. Lymphat Res Biol. 2014 Mar;12(1):23-31. doi: 10.1089/lrb.2013.0028. Epub 2014 Feb 6.

  PMID: 24502300 BACKGROUND

• Gebruers N, Truijen S, Engelborghs S, De Deyn PP. Volumetric evaluation of upper extremities in 250 healthy persons. Clin Physiol Funct Imaging. 2007 Jan;27(1):17-22. doi: 10.1111/j.1475-097X.2007.00708.x.

  PMID: 17204033 BACKGROUND

• Tan IC, Maus EA, Rasmussen JC, Marshall MV, Adams KE, Fife CE, Smith LA, Chan W, Sevick-Muraca EM. Assessment of lymphatic contractile function after manual lymphatic drainage using near-infrared fluorescence imaging. Arch Phys Med Rehabil. 2011 May;92(5):756-764.e1. doi: 10.1016/j.apmr.2010.12.027.

  PMID: 21530723 BACKGROUND

• De Vrieze T, Gebruers N, Nevelsteen I, Thomis S, De Groef A, Tjalma WAA, Belgrado JP, Vandermeeren L, Monten C, Hanssens M, Asnong A, Dams L, Van der Gucht E, Heroes AK, Devoogdt N. Does Manual Lymphatic Drainage Add Value in Reducing Suprafascial Fluid Accumulation and Skin Elasticity in Patients With Breast Cancer-Related Lymphedema? Phys Ther. 2022 Dec 6;102(12):pzac137. doi: 10.1093/ptj/pzac137.

  PMID: 36209432 DERIVED

• De Vrieze T, Gebruers N, Nevelsteen I, Fieuws S, Thomis S, De Groef A, Tjalma WA, Belgrado JP, Vandermeeren L, Monten C, Hanssens M, Devoogdt N. Manual lymphatic drainage with or without fluoroscopy guidance did not substantially improve the effect of decongestive lymphatic therapy in people with breast cancer-related lymphoedema (EFforT-BCRL trial): a multicentre randomised trial. J Physiother. 2022 Apr;68(2):110-122. doi: 10.1016/j.jphys.2022.03.010. Epub 2022 Apr 12.

  PMID: 35428594 DERIVED

• Thomis S, Helberg M, Kleiman J, Vrieze T, Heroes AK, Fourneau I, Devoogdt N. The Interrater Reliability of the Scoring of the Lymphatic Architecture and Transport Through Near-InfraRed Fluorescence Lymphatic Imaging in Patients with Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2022 Apr;20(2):133-143. doi: 10.1089/lrb.2020.0105. Epub 2021 Jun 2.

  PMID: 34077678 DERIVED

• De Vrieze T, Gebruers N, Nevelsteen I, Tjalma WAA, Thomis S, De Groef A, Dams L, Haenen V, Devoogdt N. Breast cancer-related lymphedema and its treatment: how big is the financial impact? Support Care Cancer. 2021 Jul;29(7):3801-3813. doi: 10.1007/s00520-020-05890-3. Epub 2020 Nov 24.

  PMID: 33236211 DERIVED

• Thomis S, Dams L, Fourneau I, De Vrieze T, Nevelsteen I, Neven P, Gebruers N, Devoogdt N. Correlation Between Clinical Assessment and Lymphofluoroscopy in Patients with Breast Cancer-Related Lymphedema: A Study of Concurrent Validity. Lymphat Res Biol. 2020 Dec;18(6):539-548. doi: 10.1089/lrb.2019.0090. Epub 2020 Mar 25.

  PMID: 32208953 DERIVED

• De Vrieze T, Gebruers N, Nevelsteen I, Tjalma WAA, Thomis S, De Groef A, Dams L, Van der Gucht E, Devoogdt N. Physical activity level and age contribute to functioning problems in patients with breast cancer-related lymphedema: a multicentre cross-sectional study. Support Care Cancer. 2020 Dec;28(12):5717-5731. doi: 10.1007/s00520-020-05375-3. Epub 2020 Mar 19.

  PMID: 32193692 DERIVED

• De Vrieze T, Frippiat J, Deltombe T, Gebruers N, Tjalma WAA, Nevelsteen I, Thomis S, Vandermeeren L, Belgrado JP, De Groef A, Devoogdt N. Cross-cultural validation of the French version of the Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema (Lymph-ICF-UL). Disabil Rehabil. 2021 Sep;43(19):2797-2804. doi: 10.1080/09638288.2020.1716271. Epub 2020 Jan 28.

  PMID: 31990592 DERIVED

• De Vrieze T, Gebruers N, Nevelsteen I, Tjalma WAA, Thomis S, De Groef A, Dams L, Devoogdt N. Responsiveness of the Lymphedema Functioning, Disability, and Health Questionnaire for Upper Limb Lymphedema in Patients with Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2020 Aug;18(4):365-373. doi: 10.1089/lrb.2019.0073. Epub 2020 Jan 22.

  PMID: 31971890 DERIVED

• De Vrieze T, Nevelsteen I, Thomis S, De Groef A, Tjalma WAA, Gebruers N, Devoogdt N. What are the economic burden and costs associated with the treatment of breast cancer-related lymphoedema? A systematic review. Support Care Cancer. 2020 Feb;28(2):439-449. doi: 10.1007/s00520-019-05101-8. Epub 2019 Oct 28.

  PMID: 31656987 DERIVED

• De Vrieze T, Gebruers N, Nevelsteen I, De Groef A, Tjalma WAA, Thomis S, Dams L, Van der Gucht E, Penen F, Devoogdt N. Reliability of the MoistureMeterD Compact Device and the Pitting Test to Evaluate Local Tissue Water in Subjects with Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2020 Apr;18(2):116-128. doi: 10.1089/lrb.2019.0013. Epub 2019 Jul 19.

  PMID: 31329510 DERIVED

• De Vrieze T, Vos L, Gebruers N, De Groef A, Dams L, Van der Gucht E, Nevelsteen I, Devoogdt N. Revision of the Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema (Lymph-ICF-UL): Reliability and Validity. Lymphat Res Biol. 2019 Jun;17(3):347-355. doi: 10.1089/lrb.2018.0025. Epub 2019 Feb 12.

  PMID: 30759059 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Interventions

Skin Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hygiene; Therapeutics

Results Point of Contact

• Title: Prof. Nele Devoogdt
• Organization: UZ Leuven

nele.devoogdt@uzleuven.be

0032 16 34 25 15

Study Officials

• Nele Devoogdt, PhD

  University of Leuven - KU Leuven and University Hospitals Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 17, 2022
• Results First Posted: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)