Investigating manual lymph drainage for lymphedema after urogenital cancer surgery
Lymphoedema and Nocturia/ Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND) for Urogenital Cancer: Randomised Controlled Trial (Pilot)
This study is testing if adding manual lymph drainage to regular care can help people with mild leg swelling after surgery for urogenital cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaanderen) |
| Trial ID | NCT05266157 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the feasibility of adding manual lymph drainage to the standard care regimen for patients experiencing mild lower limb lymphedema following pelvic lymph node dissection for urogenital cancer. Participants will receive usual care, which includes skin care, exercises, and compression stockings, alongside the manual lymph drainage intervention. The study focuses on patients who develop lymphedema within the first year after their surgery, assessing the potential benefits of this additional treatment approach.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone pelvic lymph node dissection for non-metastatic urogenital cancer and are experiencing early signs of lower limb lymphedema.
Not a fit: Patients with evidence of metastatic disease or clinical signs of chronic venous insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of lymphedema, improving patients' quality of life and limb function.
How similar studies have performed: While the specific combination of manual lymph drainage with standard care has not been previously investigated, similar approaches in managing lymphedema have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients included in the prospective observational study and developing lymphoedema within the first year after surgery * Before inclusion, written informed consent must be given according to ICH/GCP, and national/local regulations. Inclusion criteria of the prospective observational study were: * Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer) * Pelvic lymph node dissection Exclusion Criteria: same as for the prospective observational study: * Radiological evidence of metastatic disease based on pelvic CT/MRI and bone scan * Clinical signs of chronic venous insufficiency
Where this trial is running
Leuven, Vlaanderen
- University Hospitals Leuven, campus Gasthuisberg — Leuven, Vlaanderen, Belgium (Recruiting)
Study contacts
- Principal investigator: Nele Devoogdt, Prof. Dr. — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Nele Devoogdt, Prof. Dr.
- Email: nele.devoogdt@uzleuven.be
- Phone: +3216342515
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.