Clinical trial · Interventional
Lymphedema After Gyneco-oncologic Treatment
Lower Limb Lymphedema After Gyneco-oncologic Therapy: Can we Prevent Irreversible Lymphedema?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genital Neoplasm | — | UNRESOLVED | — |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compressive garments class II | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control arm: no compressive garments
- description
- Patients detected with early stage LLL (0-1 ISL stadia) start with education and preventive measures.
- type
- EXPERIMENTAL
- label
- Interventional arm: start of CC2 compressive garments
- description
- Patients in the experimental arm and detected with early stage LLL (0-1 ISL stadia) start with CC2 compressive garments in addition to education and preventive measures.
- interventionNames
- Device: Compressive garments class II
Primary outcomes (2)
- measure
- Incidence rate of LLL
- timeFrame
- From diagnosis until 2 years after last oncologic treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (18)
- BACKGROUNDYost KJ, Cheville AL, Weaver AL, Al Hilli M, Dowdy SC. Development and validation of a self-report lower-extremity lymphedema screening questionnaire in women. Phys Ther. 2013 May;93(5):694-703. doi: 10.2522/ptj.20120088. Epub 2013 Jan 3. PMID 23288911
- BACKGROUNDHareyama H, Hada K, Goto K, Watanabe S, Hakoyama M, Oku K, Hayakashi Y, Hirayama E, Okuyama K. Prevalence, classification, and risk factors for postoperative lower extremity lymphedema in women with gynecologic malignancies: a retrospective study. Int J Gynecol Cancer. 2015 May;25(4):751-7. doi: 10.1097/IGC.0000000000000405. PMID 25723779
- BACKGROUNDMendivil AA, Rettenmaier MA, Abaid LN, Brown JV 3rd, Micha JP, Lopez KL, Goldstein BH. Lower-extremity lymphedema following management for endometrial and cervical cancer. Surg Oncol. 2016 Sep;25(3):200-4. doi: 10.1016/j.suronc.2016.05.015. Epub 2016 May 20. PMID 27566023
- BACKGROUNDBiglia N, Zanfagnin V, Daniele A, Robba E, Bounous VE. Lower Body Lymphedema in Patients with Gynecologic Cancer. Anticancer Res. 2017 Aug;37(8):4005-4015. doi: 10.21873/anticanres.11785. PMID 28739682
- BACKGROUNDCarlson JW, Kauderer J, Hutson A, Carter J, Armer J, Lockwood S, Nolte S, Stewart BR, Wenzel L, Walker J, Fleury A, Bonebrake A, Soper J, Mathews C, Zivanovic O, Richards WE, Tan A, Alberts DS, Barakat RR. GOG 244-The lymphedema and gynecologic cancer (LEG) study: Incidence and risk factors in newly diagnosed patients. Gynecol Oncol. 2020 Feb;156(2):467-474. doi: 10.1016/j.ygyno.2019.10.009. Epub 2019 Dec 16. PMID 31837831
- BACKGROUNDDe Vrieze T, Gebruers N, Nevelsteen I, De Groef A, Tjalma WAA, Thomis S, Dams L, Van der Gucht E, Penen F, Devoogdt N. Reliability of the MoistureMeterD Compact Device and the Pitting Test to Evaluate Local Tissue Water in Subjects with Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2020 Apr;18(2):116-128. doi: 10.1089/lrb.2019.0013. Epub 2019 Jul 19.