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

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Lower Limb Lymphedema; Urogenital Cancer

Treatments: Other: Usual care; Other: Manual lymph drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT05266157

s66072 RCT

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Usual care

Active Comparator group

Description:

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.

Treatment:

Other: Usual care

Additional manual lymph drainage

Experimental group

Description:

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.

Treatment:

Other: Manual lymph drainage

Other: Usual care