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

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ClinicalTrials.gov Identifier: NCT03991897
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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 a isocaloric diet.


Condition or disease Intervention/treatment Phase
Lymphedema Ketogenic Dieting Dietary Supplement: Ketogenic diet Dietary Supplement: Isocaloric diet Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

After baseline assessment, patients will be randomized in one of the treatment groups.

Randomization is performed according to 'www.randomization.com'. This free generator randomizes each subject to a single treatment by using the method of randomly permuted blocks.

Assessments are performed by a person blinded to the treatment allocation groups.

Randomization will be stratified for baseline lymphedema volume (3-9.9%, 10.0-19.9% and ≥20%), affected limb (arm or leg) and gender (females or males). The staff members who perform the measurements are blinded for the allocation.

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The staff members who perform the measurements are blinded for the allocation.
Primary Purpose: Treatment
Official Title: Ketogenic Diet: a Novel Metabolic Strategy to Treat Lymphedema Patients?
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : January 7, 2023
Estimated Study Completion Date : January 7, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Experimental: Ketogenic diet

the intervention will consist of 3 phases: a one week run-in period, 24 weeks strict KD and 24 weeks Modified Atkins Diet.

Every day, 40 g of KetoCal, a nutritionally complete ready-to-drink liquid, is foreseen to ensure adequate amounts of vitamins and minerals and to ensure ketosis during the night (some patients drink some sips of the shake during the night). During this run-in period, patients will become familiar with their diet and, in particular, they will learn which foods are allowed and which are not.

Dietary Supplement: Ketogenic diet
Ketocal, a nutritionally complete ready-to-drink liquid, is foreseen to ensure adequate amounts of vitamins and minerals will be used. After 24 weeks a Modified Atkins diet will be started.

Active Comparator: Isocaloric diet
During the run-in period, the dietician will discuss the diet and maintenance of an isocaloric diet with the patients. As such, the diet of the control group will not change from their normal dietary pattern, unless a patient is following an Atkins-like diet. In the latter case, the patient will be asked to change the diet to a normal Belgian diet.
Dietary Supplement: Isocaloric diet
Patients will follow an isocaloric diet




Primary Outcome Measures :
  1. Change in edema volume at 24 weeks [ Time Frame: up to 24 weeks ]
    measured with volumeter

  2. Change in edema volume at 24 weeks [ Time Frame: up to 24 weeks ]
    Measured with tape circumference

  3. Change in lymphatic transport [ Time Frame: up to 48 weeks ]
    measured by lymphofluoroscopy

  4. Change in lymphatic transport [ Time Frame: up to 48 weeks ]
    Measured with lymphoscintigraphy


Secondary Outcome Measures :
  1. Change in edema volume at 12 and 48 weeks [ Time Frame: up to 48 weeks ]
    measured with volumeter

  2. Change in edema volume at 12 and 48 weeks [ Time Frame: up to 48 weeks ]
    measured with tape circumference

  3. Changed extracellular volume [ Time Frame: up to 48 weeks ]
    measured with BioImpedance Spectroscopy

  4. Changed quality of life [ Time Frame: up to 48 weeks ]
    measured with QOL questionnaire, a scale from 0-10 on 16 items, how higher the score, how higher the QOL

  5. Changed quality of life [ Time Frame: up to 48 weeks ]
    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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991897


Contacts
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Contact: Sarah Thomis, MD 003216346948 sarah.thomis@uzleuven.be
Contact: Christoph Matthys, PhD 003216342655 christophe.matthys@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Sarah Thomis, MD    003216346948    sarah.thomis@uzleuven.be   
Contact: Wendy Leus    003216341759    wendy.leus@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Sarah Thomis, MD Universitaire Ziekenhuizen Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03991897     History of Changes
Other Study ID Numbers: S61767
2018-002968-10 ( EudraCT Number )
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases