Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL

• Register: ClinicalTrials.gov
• Last refreshed on: 21 March 2022
• Main ID: NCT02609724
• Date of registration: 17/11/2015
• Prospective Registration: Yes
• Primary sponsor: Universitaire Ziekenhuizen Leuven
• Public title: Effectiveness of Fluoroscopy-guided MLD for Treatment of BCRL EFforT-BCRL
• Scientific 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
• Date of first enrolment: January 2016
• Target sample size: 194
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02609724
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: Nele Devoogdt, PhD
• Affiliation: University of Leuven - KU Leuven and University Hospitals Leuven

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lymphedema

Breast Neoplasm

Intervention(s)

Other: Traditional MLD

Other: Placebo MLD

Other: Skin care

Other: Compression therapy

Other: Fluoroscopy-guided MLD

Other: Information

Primary Outcome(s)

Lymphoedema Volume at the Level of the Arm/ Hand [Time Frame: Primary endpoint = After 3 weeks of intensive treatment]

Stagnation of Fluid at Level of the Shoulder/ Trunk [Time Frame: Primary endpoint = After 3 weeks of intensive treatment]

Secondary Outcome(s)

Local Tissue Water at the Level of the Arm and Trunk [Time Frame: After 3 weeks of intensive treatment phase, after 1, 3, 6 months of maintenance treatments and after 6 months of follow-up]

Manual Lymphatic Drainage (MLD)-Specific Treatment Satisfaction [Time Frame: Between baseline and the end of the follow-up phase (12 months)]

Hardness (Fibrosis) of the Skin at the Level of the Arm and Trunk Evaluated Through Palpation [Time Frame: After 3 weeks of intensive treatment, 1, 3, 6 months of maintenance treatment and 6 months of follow-up]

Overall Treatment Satisfaction [Time Frame: Between baseline and the end of the follow-up phase (12 months)]

Problems in Functioning Related to Development of Breast Cancer-related Lymphoedema [Time Frame: After 3 weeks of intensive treatment, 1, 3, 6 months of maintenance treatment and 6 months of follow-up]

Thickness of the Cutis and Subcutis of the Arm and Trunk Evaluated by Palpation (Pinch Test) [Time Frame: After 3 weeks of intensive treatment, 1, 3, 6 months of maintenance treatment and 6 months of follow-up]

Extracellular Fluid in the Upper Limb [Time Frame: 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 [Time Frame: After 3 weeks of intensive treatment, 1, 3, 6 months of maintenance treatment and 6 months of follow-up]

Quality of Life Score [Time Frame: After 3 weeks of intensive treatment and 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 [Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment and 6 months of follow-up]

Lymphatic Architecture and Function [Time Frame: After 3 weeks of intensive treatment and 6 months of maintenance treatment]

Number of Episodes of Erysipelas [Time Frame: Between baseline and the end of the follow-up phase (12 months)]

Secondary ID(s)

IWT150178

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Agentschap voor Innovatie door Wetenschap en Technologie

Results

• Results available: Yes
• Date Posted: 07/03/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02609724