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

Primary Purpose

Lower Limb Lymphedema, Urogenital Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Manual lymph drainage
Usual care
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb Lymphedema focused on measuring manual lymph drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Leuven, campus GasthuisbergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

Additional manual lymph drainage

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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
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.
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.
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.
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.
Change of body weight
Body weight will be measured with an electronic balance
Infection rate
Number of infection episodes during the previous 6 months is questioned
Feasibility of the trial: number of patients accepting to participate
Number of patients accepting to participate in the randomized controlled pilot trial
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.
Feasibility of the trial: registration of difficulties
Difficulties concerning the intervention will be registered
Feasibility of the trial: Number of drop-outs in each group
The number of drop-outs in both the experimental as the control group

Secondary Outcome Measures

Full Information

First Posted
January 17, 2022
Last Updated
February 22, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05266157
Brief Title
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection for Urogenital Cancer
Acronym
UroLymph
Official Title
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND) for Urogenital Cancer: Randomised Controlled Trial (Pilot)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Lymphedema, Urogenital Cancer
Keywords
manual lymph drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm 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.
Arm Title
Additional manual lymph drainage
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Manual lymph drainage
Intervention Description
Manual lymph drainage
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
skin care, exercise and compression stocking
Primary Outcome Measure Information:
Title
Change of lymphoedema-specific quality of life
Description
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.
Time Frame
Baseline-3-6-12 months
Title
Change of volume of the lower limb
Description
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
Time Frame
Baseline-3-6-12 months
Title
Change of health-related quality of life
Description
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.
Time Frame
Baseline-3-6-12 months
Title
Change of physical activity level
Description
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.
Time Frame
Baseline-3-6-12 months
Title
Change of water content at the level of the legs/ midline region
Description
Water content in the leg and midline region will be measured using the MoistureMeterD Compact.
Time Frame
Baseline-3-6-12 months
Title
Change of extracellular fluid at the level of the legs/ midline region
Description
Extracellular fluid in the lower limb will be measured with bio-impedance spectroscopy.
Time Frame
Baseline-3-6-12 months
Title
Change of body weight
Description
Body weight will be measured with an electronic balance
Time Frame
Baseline-3-6-12 months
Title
Infection rate
Description
Number of infection episodes during the previous 6 months is questioned
Time Frame
Baseline-6-12 months
Title
Feasibility of the trial: number of patients accepting to participate
Description
Number of patients accepting to participate in the randomized controlled pilot trial
Time Frame
12 months
Title
Feasibility of the trial: information about the intervention
Description
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.
Time Frame
12 months
Title
Feasibility of the trial: registration of difficulties
Description
Difficulties concerning the intervention will be registered
Time Frame
12 months
Title
Feasibility of the trial: Number of drop-outs in each group
Description
The number of drop-outs in both the experimental as the control group
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nele Devoogdt, Prof. Dr.
Phone
+3216342515
Email
nele.devoogdt@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Van Calster, MSc.
Email
charlotte.vancalster@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nele Devoogdt, Prof. Dr.
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven, campus Gasthuisberg
City
Leuven
State/Province
Vlaanderen
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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