Ketogenic diet and ketone ester to reduce arm lymphedema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with early unilateral arm lymphedema will be randomized to a ketogenic diet or an isocaloric control diet, and some groups will receive ketone ester supplementation, to induce nutritional ketosis and compare outcomes. The study will measure limb volume differences, dermal backflow and markers of lymphatic transport to determine changes in edema and function. Eligible participants are adults with stage 1 to 2b lymphedema that started within one year after lymph node dissection and who can give informed consent in Dutch. The trial is motivated by mouse proof-of-concept data showing reduced edema and improved lymphatic transport under ketogenic conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• UZ Leuven
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Nicolas Timmermans, Msc — KU Leuven
• Study coordinator: Sarah Thomis, MD
• Email: sarah.thomis@uzleuven.be
• Phone: 003216346948

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Use of reconstructive microsurgery to treat lymphedema

  This study tests whether reconstructive microsurgery, with or without the help of indocyanine green imaging, can help people with lymphedema feel and function better by improving lymphatic drainage.

  Recruiting Istituto Ortopedico Rizzoli · Bologna · NCT07889856

• Predicting lymphedema risk in inflammatory breast cancer patients using preoperative body impedance analysis

  This study tests whether a preoperative bioimpedance test can help identify IBC patients who are at risk for developing lymphedema.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT07855627

• Boosted compression for lower limb edema

  This study tests whether applying a multicomponent short-stretch bandage three times daily (boosted compression) helps reduce edema faster in people with chronic edema or lymphedema of the legs, compared with the standard single daily bandage.

  Recruiting at 4 sites Universiteit Antwerpen · Edegem, Antwerp and 3 other locations · NCT07708662

• Erector Spinae Block vs Paravertebral Block for Chronic Pain After Mastectomy

  This trial tests whether an erector spinae block can better prevent chronic pain after mastectomy than a paravertebral block in adults 18–80.

  Recruiting American University of Beirut Medical Center · Beirut · NCT07561411

• Resistance exercise for people with lower-limb lymphedema

  This study tests whether short periods of supervised resistance exercise, with and without compression garments, change swelling or symptoms in people with lower-limb lymphedema.

  Recruiting Herlev and Gentofte Hospital · Herlev · NCT07558317

• Tracking body composition changes after breast cancer treatment

  This project will see how muscle mass and fat distribution change over two years in adults treated for stage I–III breast cancer.

  Recruiting Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · New Taipei City, Xindian Dist · NCT07472803

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.