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

NCT05266157 | Recruiting

• 1 other identifier: s66072 RCT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Lymphedema; Urogenital Cancer

Keywords

manual lymph drainage

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

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.

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.

Other: Manual lymph drainage; Other: Usual care

Interventions

Manual lymph drainage OTHER

Manual lymph drainage

Additional manual lymph drainage

Usual care OTHER

skin care, exercise and compression stocking

Additional manual lymph drainage; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients included in the prospective observational study and developing lymphoedema within the first year after surgery
• Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer)
• Pelvic lymph node dissection

You may not qualify if:

• Radiological evidence of metastatic disease based on pelvic CT/MRI and bone scan
• Clinical signs of chronic venous insufficiency

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven, campus Gasthuisberg

Leuven, Flanders, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Urogenital Neoplasms

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nele Devoogdt, Prof. Dr.

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nele Devoogdt, Prof. Dr.

CONTACT

+3216342515; nele.devoogdt@uzleuven.be

Charlotte Van Calster, MSc.

CONTACT

charlotte.vancalster@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: March 4, 2022
• Study Start: January 21, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-03

Locations

BE (1)