NCT05469945 Lymphedema After Gyneco-oncologic Treatment
| NCT ID | NCT05469945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 218 participants |
| Start Date | 2022-06-22 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 218 participants in total. It began in 2022-06-22 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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) * Severe injury, surgery or deformation of the legs or groins in the past * Vascular malformation of the leg or untreated venous insufficiency with oedema (CEAP C4 or more) * Mental or psychological problems, inability to comply to the study protocol * First treatment administered \> 2 weeks before * Clinical signs and symptoms of lymphedema present (ISL stage 0 or higher) at the moment of intake
Contact & Investigator
Chris Monten, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT05469945 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05469945 currently recruiting?
Yes, NCT05469945 is actively recruiting participants. Contact the research team at chris.monten@uzgent.be for enrollment information.
Where is the NCT05469945 trial being conducted?
This trial is being conducted at Ghent, Belgium, Leuven, Belgium.
Who is sponsoring the NCT05469945 clinical trial?
NCT05469945 is sponsored by University Hospital, Ghent. The principal investigator is Chris Monten, MD, PhD at University Hospital, Ghent. The trial plans to enroll 218 participants.