Actively Recruiting
Lymphedema After Gyneco-oncologic Treatment
Led by University Hospital, Ghent · Updated on 2024-06-20
218
Participants Needed
2
Research Sites
314 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
U
University Hospital, Louvain
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lymphedema After Gyneco-oncologic Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent (ICF)
- Female patient, recently diagnosed with gynecologic cancer (cervix, endometrium, vulva, vagina, ovaries, etc.) and candidate for curative treatment
- Age 18 years or older
- Understanding of the Dutch language
- Able to understand the informed consent and willing to comply with the protocol, including use of diary or app and timely completion of requested questionnaires
You will not qualify if you...
- History of treatment for gynecologic cancer
- Concurrent second primary tumor(s)
- Pregnancy or pregnancy planned within 2 years
- Known metastasized cancer at the time of inclusion
- Severe injury, surgery, or deformation of the legs or groins in the past
- Vascular malformation of the leg or untreated venous insufficiency with edema (CEAP C4 or more)
- Mental or psychological problems causing inability to comply with the study protocol
- First treatment administered more than 2 weeks before inclusion
- Clinical signs and symptoms of lymphedema present (ISL stage 0 or higher) at the moment of intake
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Ghent University Hospital, Dept. Radiotherapy-Oncology
Ghent, Belgium, 9000
Actively Recruiting
2
University Hospital, Louvain
Leuven, Belgium, 3000
Actively Recruiting
Research Team
C
Chris Monten, MD, PhD
CONTACT
C
Caren Randon, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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