Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND) for Urogenital Cancer: Randomised Controlled Trial (Pilot)

Conditions
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Lower Limb Lymphedema, Urogenital Cancer

Intervention / Treatment
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* Other: Manual lymph drainage
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>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<br>* skin care, exercise and compression stocking<br>|
| Experimental: Additional manual lymph drainage<br>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<br>* Manual lymph drainage<br>Other: Usual care<br>* skin care, exercise and compression stocking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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. | 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. | 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. | Baseline-3-6-12 months | 
| Change of body weight | Body weight will be measured with an electronic balance | Baseline-3-6-12 months | 
| Infection rate | Number of infection episodes during the previous 6 months is questioned | 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 | 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. | 12 months | 
| Feasibility of the trial: registration of difficulties | Difficulties concerning the intervention will be registered | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manual lymph drainage