Assessing lymphedema in women treated for gynecologic cancer
Lower Limb Lymphedema After Gyneco-oncologic Therapy: Can we Prevent Irreversible Lymphedema?
NA · University Hospital, Ghent · NCT05469945
This study is trying to see how often women treated for gynecologic cancer develop swelling in their legs and if wearing special compression garments can help prevent it from getting worse.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 218 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent (other) |
| Locations | 2 sites (Ghent and 1 other locations) |
| Trial ID | NCT05469945 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older, recently diagnosed with gynecologic cancer and eligible for curative treatment.
Not a fit: Patients with a history of treatment for gynecologic cancer or those with severe leg injuries or vascular malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for lymphedema, enhancing the quality of life for patients recovering from gynecologic cancer.
How similar studies have performed: While many studies focus on upper limb lymphedema, this approach to lower limb lymphedema is less explored, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphedema, Genital Neoplasm, Lymphedema of the lower limb, Gynaecologic cancer, Sexual well-being, Quality of Life, Cost-investment, Time-investment