Clinical trial NCT05266157: Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer
Official title: Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND) for Urogenital Cancer: Randomised Controlled Trial (Pilot)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Limb Lymphedema
Urogenital Cancer
Keywords: manual lymph drainage
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of lymphoedema-specific quality of life
timeFrame: Baseline-3-6-12 months
measure: Change of volume of the lower limb
timeFrame: Baseline-3-6-12 months
measure: Change of health-related quality of life
timeFrame: Baseline-3-6-12 months
measure: Change of physical activity level
timeFrame: Baseline-3-6-12 months
measure: Change of water content at the level of the legs/ midline region
timeFrame: Baseline-3-6-12 months
measure: Change of extracellular fluid at the level of the legs/ midline region
timeFrame: Baseline-3-6-12 months
measure: Change of body weight
timeFrame: Baseline-3-6-12 months
measure: Infection rate
timeFrame: Baseline-6-12 months
measure: Feasibility of the trial: number of patients accepting to participate
timeFrame: 12 months
measure: Feasibility of the trial: information about the intervention
timeFrame: 12 months
measure: Feasibility of the trial: registration of difficulties
timeFrame: 12 months
measure: Feasibility of the trial: Number of drop-outs in each group
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, campus Gasthuisberg
state: Vlaanderen
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Nele Devoogdt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: