An interventional study of Manual lymph drainage and Usual care in Lower Limb Lymphedema and Urogenital Cancer, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
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Among 12 studies in Urogenital Neoplasms with a site in Belgium — 6 open to participants now, 7 under way, 1 of them phase 3. Urogenital Neoplasms · Belgium.
Among the 12 studies in Urogenital Neoplasms with a site in Belgium, this one is one of 5 that started in 2022, is one of 3 with no phase, and was the 6th registered.
173 studies on the registry are indexed under Urogenital Neoplasms; 47 are open to participants now.
Browse Urogenital Neoplasms studies →6 of the 12 studies in Urogenital Neoplasms with a site in Belgium are open now. Recruiting first, the newest first:
The Netherlands Cancer Institute · Sites in Belgium, Netherlands
Ages 18+ · Men only
Algemeen Ziekenhuis Maria Middelares · Sites in Belgium
Ages 18+
KU Leuven · Sites in Belgium
Ages 18+
Blue Earth Therapeutics Ltd · Sites in Belgium, United States, Germany and 2 more countries
Ages 18+ · Men only
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Ages 18+
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 45 Urogenital Neoplasms studies recruiting now, 37 (82%) set no upper age limit and 6 (13%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 3
First in 2008; this study’s year is marked. 5 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 60 across 122 interventional studies indexed under Urogenital Neoplasms.
Median enrollment 150 across the 9 interventional studies, 150 across the 3 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
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3 of 12 have an industry lead sponsor. The 9 most frequent:
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Universitaire Ziekenhuizen KU Leuven has 2 studies filed under Urogenital Neoplasms — fewer than ten, so there is no comparison to draw.
2 of the studies in Urogenital Neoplasms with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05300308Universitaire Ziekenhuizen KU LeuvenLymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer | 2026-11 |
| NCT06835426Algemeen Ziekenhuis Maria MiddelaresHigh-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins | 2027-01-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 12 studies in Urogenital Neoplasms with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Lymphoedema is the result of a dysfunction in the lymphatic system and is characterized by excessive retention of lymphatic fluid in the interstitial compartment, adipose deposition and chronic tissue inflammation resulting in fibrosis. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function.
The added value of manual lymph drainage, applied in patients with mild (early) lower limb lymphoedema and in addition to skin care, exercises and a compression stocking, has never been investigated.
Therefore, the objective of this randomised controlled pilot trial is to investigate the feasibility of a trial about the added value of manual lymph drainage (to skin care, exercises and wearing compression stocking) in patients with mild (early) lower limb lymphoedema. In fact, the investigators want to determine the sample size for a trial investigating the effectiveness of MLD and want to investigate the feasibility of the study design.
Inclusion Criteria:
Inclusion criteria of the prospective observational study were:
Exclusion Criteria: same as for the prospective observational study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Skin care, exercise and compression stocking: The patient has to wear custom-made compression thigh stocking(s) in case of unilateral/ bilateral swelling of the leg and has to wear a bermuda in case of swelling of the midline region. The patient continues the skin care and continues/ restarts exercise therapy with the home physical therapist 2 times a week. Frequency of exercises is gradually decreased: M1-3 2x/w, M4-6 1x/w, M7-9 1x/M; M10-12 only self-exercises.
Other: Usual care
Usual care + manual lymph drainage. Manual lymph drainage is performed by the home physical therapist. Every session lasts for 30 minutes. Frequency of manual lymph drainage is gradually decreased: M1-3 2x/w, M4-6 1x/w, M7-9 1x/M; M10-12 only self-MLD.
Other: Manual lymph drainage · Other: Usual care
Manual lymph drainage
skin care, exercise and compression stocking
Change of lymphoedema-specific quality of life
Lymphoedema-specific quality of life will be evaluated using the Lymph-ICL-LL questionnaire: The Lymph-ICF-LL is a descriptive, evaluative tool containing 28 questions about impairments in function, activity limitations, and participation restrictions in patients with lower limb lymphoedema. The questionnaire has 5 domains: physical function, mental function, general tasks/household activities, mobility activities, and life domains/social life.
Time frame: Baseline-3-6-12 months
Change of volume of the lower limb
Volume measurements will be done at midline, leg and foot. Volume midline: circumference at the level of the hip and distance navel - pubic bone, with tapeline. Volume leg: circumference measurements in sitting position, with knee extension, foot supported by chair; reference point is the upper border of the patella and every 4cm up to the groin and to the ankle, with perimeter Volume foot: figure of 8 method: in sitting position, with knee extension, foot supported by chair and relaxed; with tapeline; make the figure 8 between the distal part of medial and lateral malleolus and the proximal border of metatarsal I and V
Time frame: Baseline-3-6-12 months
Change of health-related quality of life
Health-related quality of life will be assessed with the EuroQol EQ-5D-5L (questionnaire). The EQ-5D, developed by the EuroQol Group, is a generic HRQoL instrument commonly used for indirect utility measurement. It is a descriptive system for health states, encompassing 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), combined with a visual analogue scale ranging from "worst imaginable health state" to "best imaginable health state". Each health dimension has 5 levels of severity (EQ-5D-5L;5L: no problems, slight problems, moderate problems, severe problems,extreme problems /unable to). Each EQ-5D health state is labelled by a code, e.g. 21531, where each digit represents the severity level of a dimension. By convention, the order of dimensions is mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time frame: Baseline-3-6-12 months
Change of physical activity level
Physical activity will be assessed with the International Physical Activity Questionnaire (IPAQ). The IPAQ is a 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old.
Time frame: Baseline-3-6-12 months
Change of water content at the level of the legs/ midline region
Water content in the leg and midline region will be measured using the MoistureMeterD Compact.
Time frame: Baseline-3-6-12 months
Change of extracellular fluid at the level of the legs/ midline region
Extracellular fluid in the lower limb will be measured with bio-impedance spectroscopy.
Time frame: Baseline-3-6-12 months
Change of body weight
Body weight will be measured with an electronic balance
Time frame: Baseline-3-6-12 months
Infection rate
Number of infection episodes during the previous 6 months is questioned
Time frame: Baseline-6-12 months
Feasibility of the trial: number of patients accepting to participate
Number of patients accepting to participate in the randomized controlled pilot trial
Time frame: 12 months
Feasibility of the trial: information about the intervention
If the participant is randomised to the intervention group with manual lymph drainage, information is collected regarding the type of lymph drainage, the number of sessions and the duration of one session.
Time frame: 12 months
Feasibility of the trial: registration of difficulties
Difficulties concerning the intervention will be registered
Time frame: 12 months
Feasibility of the trial: Number of drop-outs in each group
The number of drop-outs in both the experimental as the control group
Time frame: 12 months
Started Jan 2022 (actual). Primary completion is estimated for Sep 2024, 31 months after the start.
Of 23 interventional studies with no phase under Urogenital Neoplasms, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 20. This study's planned 31 months is below that.
How these figures are worked out, and which studies are left out of them.
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