Assessing lymphedema in women treated for gynecologic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to inventory the incidence of lower limb lymphedema in women diagnosed with and treated for gynecologic cancer. It will include 400 patients from diagnosis until two weeks after their first treatment, followed for up to two years to monitor the occurrence of lymphedema. Data will be collected on symptoms, quality of life, and associated costs, providing insights into the impact of lymphedema on patients. Additionally, patients developing early-stage lymphedema will enter a sub-cohort to evaluate the effectiveness of class II compressive garments in preventing progression to advanced lymphedema.

Why it matters

Who can join: the full rules

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

Where it's running

• Ghent University Hospital, Dept. Radiotherapy-Oncology
  Ghent, Belgium Recruiting
• University Hospital, Louvain
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Chris Monten, MD, PhD — University Hospital, Ghent
• Study coordinator: Chris Monten, MD, PhD
• Email: chris.monten@uzgent.be
• Phone: 093320749

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.