Lower Limb LymphedemaUroLymphNCT05266157
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer
A study testing Manual lymph drainage in people with Lower Limb Lymphedema and Urogenital Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Lymphedema, Urogenital Cancer
- What is being tested?
- Manual lymph drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Jan 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients included in the prospective observational study and developing lymphoedema within the first year after surgery
- Before inclusion, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Inclusion criteria of the prospective observational study were:
- Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer)
- Pelvic lymph node dissection
- Exclusion Criteria: same as for the prospective observational study:
- Radiological evidence of metastatic disease based on pelvic CT/MRI and bone scan
- Clinical signs of chronic venous insufficiency
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Charlotte Van Calster, MSc. contact
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven, campus Gasthuisberg
Leuven, Flanders, 3000
About this study
Official title: Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND) for Urogenital Cancer: Randomised Controlled Trial (Pilot)
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.
- Conditions
- Lower Limb Lymphedema, Urogenital Cancer
- Being tested
- Manual lymph drainage, Usual care
- Keywords
- manual lymph drainage
- Medical subject headings
- Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual lymph drainageOther
Manual lymph drainage
Usual careOther
skin care, exercise and compression stocking
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | 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. Receives: Other: Usual care |
| Additional manual lymph drainage | Experimental | 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. Receives: Other: Manual lymph drainage; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline-3-6-12 months
Change of body weight
Body weight will be measured with an electronic balance
Measured: Baseline-3-6-12 months
Infection rate
Number of infection episodes during the previous 6 months is questioned
Measured: 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
Measured: 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.
Measured: 12 months
Feasibility of the trial: registration of difficulties
Difficulties concerning the intervention will be registered
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start21 Jan 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb LymphedemaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nele Devoogdt, Prof. Dr., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266157
- Sponsor's protocol ID
- s66072 RCT
- Acronym
- UroLymph
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND) for Urogenital Cancer: Randomised Controlled Trial (Pilot)
- ClinicalTrials.gov ID
- NCT05266157
- Acronym / sponsor ID
- UroLymph / s66072 RCT
- Conditions
- Lower Limb Lymphedema, Urogenital Cancer
- Keywords
- manual lymph drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careSkin 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. |
| Additional manual lymph drainage | Experimental | Other: Manual lymph drainage, Other: Usual careUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients included in the prospective observational study and developing lymphoedema within the first year after surgery
- Before inclusion, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer)
- Pelvic lymph node dissection
- Radiological evidence of metastatic disease based on pelvic CT/MRI and bone scan
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual lymph drainageManual lymph drainage | Other | Additional manual lymph drainage |
| Usual careskin care, exercise and compression stocking | Other | Additional manual lymph drainage, Usual care |
Primary outcome
Change of lymphoedema-specific quality of life
Time frame: Baseline-3-6-12 months
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.
Change of volume of the lower limb
Time frame: Baseline-3-6-12 months
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
Change of health-related quality of life
Time frame: Baseline-3-6-12 months
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.
Change of physical activity level
Time frame: Baseline-3-6-12 months
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.
Change of water content at the level of the legs/ midline region
Time frame: Baseline-3-6-12 months
Water content in the leg and midline region will be measured using the MoistureMeterD Compact.
Change of extracellular fluid at the level of the legs/ midline region
Time frame: Baseline-3-6-12 months
Extracellular fluid in the lower limb will be measured with bio-impedance spectroscopy.
Change of body weight
Time frame: Baseline-3-6-12 months
Body weight will be measured with an electronic balance
Infection rate
Time frame: Baseline-6-12 months
Number of infection episodes during the previous 6 months is questioned
Feasibility of the trial: number of patients accepting to participate
Time frame: 12 months
Number of patients accepting to participate in the randomized controlled pilot trial
Feasibility of the trial: information about the intervention
Time frame: 12 months
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.
Feasibility of the trial: registration of difficulties
Time frame: 12 months
Difficulties concerning the intervention will be registered
Feasibility of the trial: Number of drop-outs in each group
Time frame: 12 months
The number of drop-outs in both the experimental as the control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Van Calster, MSc. contact
Nele Devoogdt, Prof. Dr. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual lymph drainage in people with Lower Limb Lymphedema and Urogenital Cancer, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nele Devoogdt, Prof. Dr. (+3216342515, nele.devoogdt@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of lymphoedema-specific quality of life (time frame: Baseline-3-6-12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.