Actively Recruiting
Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-12-03
81
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lymphedema is a debilitating disorder that severely impairs the quality of life of the patients and requires life-long attention. Treatment for lymphatic dysfunction remains largely symptomatic, without real cure. According to the International Society of Lymphology, lymphedema has to be treated with Decongestive Lymphatic Therapy. Research in the lab of Angiogenesis and Vascular Metabolism (PCA lab) reported in mice that metabolism of endothelial cells controls vessel sprouting. Experiments showed that a ketogenic diet (KD) reduced the edema of the mice tail and enhanced the lymphatic transport. Based on these proof-of-concept data, the investigators plan to test this innovative concept to ameliorate lymph vessel dysfunction in lymphedema patients. Randomisation will be performed between a ketogenic diet and an isocaloric diet with and without ketone ester supplementation.
CONDITIONS
Official Title
Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Unilateral lymphedema after arm lymph node dissection
- Lymphedema onset less than one year before starting therapy
- Lymphedema volume difference greater than 3% between arms
- Lymphedema stage 1, 2a, or 2b
- Not pregnant and willing to use birth control until study ends
- Provided written and oral informed consent
- Able to understand Dutch
You will not qualify if you...
- Under 18 years of age
- Edema caused by other reasons or outside specified stage/onset
- Active cancer present
- Pregnant or breastfeeding
- Unable to participate for the entire study period
- Mentally or physically unable to take part
- Serious illnesses like kidney failure, liver problems, heart failure, or neurological issues
- Diabetes or other metabolic diseases
- Allergic to indocyanine green or iodine, or have hyperthyroidism
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
S
Sarah Thomis, MD
CONTACT
C
Christoph Matthys, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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