Ketogenic Diet: a Novel Metabolic Strategy to Treat Lymphedema Patients?

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jun 18, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring whether a ketogenic diet, which is low in carbohydrates and high in fats, can help improve lymphedema in patients. Lymphedema is a condition that causes swelling, usually in the arms or legs, and can significantly affect daily life. Researchers previously found that this diet helped reduce swelling in mice, and now they want to see if it can have similar benefits for people with lymphedema. Participants in the study will be randomly assigned to follow either a ketogenic diet or a similar diet that has the same number of calories.

To be eligible for this study, participants should be at least 18 years old and have lymphedema in one arm or leg that started less than a year ago. They should also have a noticeable difference in size between their affected limb and the other limb. Participants will need to understand Dutch and provide consent to take part in the study. Throughout the trial, participants will be monitored to see how their condition responds to the diet. This research could lead to new ways to help manage lymphedema and improve the quality of life for those affected.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \>18 years;
• • unilateral lymphedema of the arm or leg after lymph node dissection
• • lymphedema onset less than a year before the therapy starts
• • lymphedema defined as \>3% volume difference between both arms/legs
• • lymphedema stage 1 or 2
• • 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.