Lymphedema After Gyneco-oncologic Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorUniversity Hospital, Ghent
About this trial
Trial developed to inventory the incidence of early and advanced stage lower limb lymphedema in patients diagnosed with and treated for gynaecologic cancer.
Four hundred patients with diagnosis stage 1-3 gynaecologic cancer will be included in an observational cohort between diagnosis until maximum 2 weeks after start of the first treatment. They will be followed for occurrence of lower limb lymphedema up till 2 years after their last treatment.
Data on signs and symptoms, quality of life, time investment and financial expenses will be collected, to provide information on the incidence and risk factors for lower limb lymphedema, and on its impact on patients, regarding quality of life, sexual well-being and time- and financial investment.
Patients developing early stage LLL enter an interventional sub-cohort, in which the effect of class II compressive garments on preventing evolution towards advanced stage LLL will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent (ICF)
Female patient, recently diagnosed with gynaecologic cancer (cervix, endometrium, vulva, vagina, ovaries…) and candidate for curative treatment
Age ≥ 18 years
Understanding of the Dutch language
Disqualifiers
History of treatment for gynaecologic cancer
Concurrent second primary tumor(s)
Pregnancy or pregnancy planned within 2 years
Known metastasized cancer at the time of inclusion (D0)
Trial design
Design model
Parallel
Treatments tested in this trial
Compressive garments class II
DeviceDaily wearing of compressive garments, especially during prolonged standing upright or strenuous activities.
Treatment groups
218 Participants
are divided into 2 treatment groupsGroup A: Control arm: no compressive garmentsNo intervention 0 interventions
Group B: Interventional arm: start of CC2 compressive garmentsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence rate of LLL
Number of patients with transition (evolution) to stage 0-3 LLL (ISL criteria) in the first two years after treatment for gynecologic cancer. We defined three potential transitions: * T1: from no LLL to reversible stage 0-1 LLL * T2: from no LLL to irreversible stage 2-3 LLL * T3: from stage 0-1 LLL to stage 2-3 LLL
Time frame
From diagnosis until 2 years after last oncologic treatment2
Incidence rate of transition from stage 0-1 LLL to stage 2-3 LLL in randomized subgroup
Number of patients diagnosed with stage 0-1 LLL within one year after treatment for gynecologic cancer and that evolve from stage 0-1 LLL to stage 2-3 LLL
Time frame
From transition to stage 0-1 LLL until 1 year afterSecondary outcomes
1
Timing of development of LLL
Registration of the timing of development of the different stages of LLL within the first two years after end of treatment
Time frame
From diagnosis until 2 years after last oncologic treatment2
Risk factors for developing LLL - per age category the number of patients that develop lower limb lymph-edema as assessed with ISL criteria
Age: the amount of time something has been alive or has existed (years)
Time frame
From diagnosis until 2 years after last oncologic treatment3
Risk factors for developing LLL - weight
Weight: In the operational definition, the weight of an object is the force measured by the operation of weighing it, which is the force it exerts on its support, expressed in kilograms (kg)
Time frame
From diagnosis until 2 years after last oncologic treatment4
Risk factors for developing LLL - height
Height: measure of vertical extent (how "tall" something or someone is) (expressed in meters)
Time frame
From diagnosis until 2 years after last oncologic treatmentOther outcomes
1
Tolerance of and compliance to preventive compressive garments as assessed with the ICC compression questionnaire
Satisfaction with compressive garments assessed with ICC compression questionnaire, evaluation of functioning, symptoms of LLL, side-effects of compressive garments, feasibility of use, frequency and duration of wearing, autonomy, improvement or deterioration of functioning on social and job-level
Time frame
From transition to stage until 1 year after2
Impact of preventive compressive garments on evolution of leg volume
Comparison of evolution of leg circumference measurement between the intervention group (compressive garments and the control group (no compressive garments), measuring leg circumference every 4cm, starting from a fixed point above the ankles to 17 measuring points above. Estimation of volume per leg is based on the truncated cone formula.
Time frame
From transition to stage until 1 year after3
Impact of preventive compressive garments on patient's time investment, including putting on and of compressive garments, washing compressive clothing, skin care...
Inventory of mean time-investment of patients in the treatment of LLL through app-based registration, and comparison of time-investment between control group (no compressive garments) and interventional group (with compressive garments)
Time frame
From transition to stage until 1 year after4
Impact of preventive compressive garments on financial investment, including reimbursed as well as out-of-pocket patient cost for compressive stockings, supplementary tools, nursing aid...
Inventory of mean financial investment of patients in the treatment of LLL through app-based registration, and comparison of time-investment between control group (no compressive garments) and interventional group (with compressive garments)
Time frame
From transition to stage until 1 year afterSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Ghent
Lead sponsor
University Hospital, Louvain
Collaborator
Kom Op Tegen Kanker
Collaborator
Source ClinicalTrials.gov