Clinical trial · Interventional
Effect of Early Compression and Exercise on Lymphedema Incidence in Patients With Gynecological Cancer
Effect of Early Compression Therapy and Individualized Exercise on Incidence of Lymphedema in Patients Treated for Gynecological Cancer: a Pilot Randomized Controlled Trial
- 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)
Objectives: 1) To evaluate the effect of early compression therapy with individualized exercise on the incidence of lower limb lymphedema at 12 months post-operatively in patients treated for gynecological cancer who are at risk of developing lymphedema; 2) To evaluate the effect of early compression therapy with individualized exercise on lower limb volume, quality of life and incidence of cellulitis infections at 12 months post-operatively in this population.
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 Neoplasms, Female | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bilateral leg compression stockings | Device | — | UNRESOLVED |
| Individualized exercise | Behavioral | — | UNRESOLVED |
| Lymphedema risk reduction | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Compression Stockings-Exercise
- description
- At T2 (4-6 weeks post-operatively), 25 study participants will be randomized to the intervention group and will be prescribed compression stockings and individualized exercise. They will also receive standard education on lymphedema risk reduction.
- interventionNames
- Device: Bilateral leg compression stockings
- Behavioral: Individualized exercise
- Behavioral: Lymphedema risk reduction
- type
- OTHER
- label
- Control Group
- description
- At T2 (4-6 weeks post-operatively), 25 study participants will be randomized to the control group and will receive standard education on lymphedema risk reduction.
- interventionNames
- Behavioral: Lymphedema risk reduction
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * above 18 years of age; * diagnosis of grade 2 or 3 endometrial cancer, or high grade type (serous or clear cell), stage 1b1 or stage 2a cervical cancer, stage 1 vulvar cancer with tumor greater than 4 cm, or stage 2 or 3 vulvar cancer; * to undergo surgical lymph node dissection. Exclusion Criteria: * recurrent diagnosis of gynecological cancer; * presence of distant metastases (stage 4 cancer); * body mass index of 35 or greater.
References
Publications (1)
- DERIVEDShallwani SM, Towers A, Newman A, Salvador S, Yung A, Gilbert L, Gotlieb WH, Zeng X, Thomas D. Feasibility of a Pilot Randomized Controlled Trial Examining a Multidimensional Intervention in Women with Gynecological Cancer at Risk of Lymphedema. Curr Oncol. 2021 Jan 13;28(1):455-470. doi: 10.3390/curroncol28010048. PMID 33450972