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New treatment option for Lymphedema
Official title Nutritional Ketosis: a Novel Metabolic Strategy to Treat Lymphedema Patients?
ClinicalTrials.gov ID: NCT03991897
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \>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
You likely can't join if
- \<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;
See the full eligibility 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
- \<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.
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.