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

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.

Study Overview

• Status: Recruiting
• Conditions: Urogenital Cancer; Lower Limb Lymphedema
• Intervention / Treatment: Other: Usual care; Other: Manual lymph drainage

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nele Devoogdt, Prof. Dr.; Phone Number: +3216342515; Email: nele.devoogdt@uzleuven.be
• Study Contact Backup: Name: Charlotte Van Calster, MSc.; Email: charlotte.vancalster@kuleuven.be

Study Locations

• Belgium
  • Vlaanderen
    • Leuven, Vlaanderen, Belgium, 3000
      • Recruiting
      • University Hospitals Leuven, Campus Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; 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; skin care, exercise and compression stocking
Experimental: Additional manual lymph drainage; 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: Usual care; skin care, exercise and compression stocking; Other: Manual lymph drainage; Manual lymph drainage

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Nele Devoogdt, Prof. Dr., Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: manual lymph drainage
• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Neoplasms by Site; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lymphedema; Urogenital Neoplasms; Nocturia; Polyuria
• Other Study ID Numbers: s66072 RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No