Lymphedema Clinical Trial
— KETOLYMPHOfficial title:
Ketogenic Diet: a Novel Metabolic Strategy to Treat Lymphedema Patients?
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 a isocaloric diet.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 7, 2024 |
Est. primary completion date | December 7, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in edema volume at 24 weeks | measured with volumeter | up to 24 weeks | |
Primary | Change in edema volume at 24 weeks | Measured with tape circumference | up to 24 weeks | |
Primary | Change in lymphatic transport | measured by lymphofluoroscopy | up to 48 weeks | |
Primary | Change in lymphatic transport | Measured with lymphoscintigraphy | up to 48 weeks | |
Secondary | Change in edema volume at 12 and 48 weeks | measured with volumeter | up to 48 weeks | |
Secondary | Change in edema volume at 12 and 48 weeks | measured with tape circumference | up to 48 weeks | |
Secondary | Changed extracellular volume | measured with BioImpedance Spectroscopy | up to 48 weeks | |
Secondary | Changed quality of life | measured with QOL questionnaire, a scale from 0-10 on 16 items, how higher the score, how higher the QOL | up to 48 weeks | |
Secondary | Changed quality of life | measured with Lymph ICF (international classification of functioning, disability and Health), a scale from 0-10 on 29 items, total score ranged from 0-100, 0-4: indicate no problem; 5-24 a small problem; 26-49: moderate problem; 50-95: severe problem; 96-100: very severe problem | up to 48 weeks |
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