Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients? (NCT03991897) | Clinical Trial Compass
RecruitingNot Applicable
Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
Belgium81 participantsStarted 2025-10-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>18 years;
* unilateral lymphedema of the arm lymph node dissection
* lymphedema onset less than a year before the therapy starts
* lymphedema defined as \>3% volume difference between both arms
* lymphedema stage 1, stage 2a or stage 2b
* absence of pregnancy at the time of enrollment and willingness to use adequate contraceptive measures until the end of the study;
* oral and written approval of the informed consent presented at the time of the consultation by the physicians;
* understanding Dutch
Exclusion Criteria:
* \<18 years;
* edema of the limb with different etiology or later stage/onset as specified in the inclusion criteria;
* presence of active cancer
* pregnancy or active breastfeeding;
* impossibility to participate for the entire study period;
* mentally or physically unable to participate to the study;
* presence of gastrointestinal intolerance or other serious illness (e.g. renal failure, hepatic dysfunction, heart failure, neurological impairment);
* presence of diabetes or other metabolic disease;
* contra-indication for the use of indocyanine green (ICG): allergy to ICG or iodine, hyperthyroidism.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying whether nutritional ketosis — through either a ketogenic diet or a ketone ester supplement — can improve lymphatic transport in lymphedema patients; could you help me understand whether my specific type and stage of lymphedema might be a reasonable fit to discuss with the research team?
2Since this trial is listed as 'Phase NA,' it seems more like a metabolic investigation than a standard drug trial — what does that mean for how much is already known about the safety and effectiveness of ketogenic approaches for lymphedema specifically?
3The study involves either following a ketogenic diet or taking a ketone ester supplement, both of which can be significant lifestyle and dietary changes — given my current health, medications, and nutritional needs, are there any risks I should be aware of before exploring this further with the investigators?
4The trial is measuring changes in lymphatic transport — could you explain what that measurement involves, how it would be done, and what the results would actually tell us about whether my lymphedema is improving?
5Before considering this trial, are there standard lymphedema treatments I haven't yet tried that might be worth pursuing first, or could participating in this study complement my current care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.