Clinical trial · Interventional
Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer
A Prospective Randomized Single Blind Phase III Trial Comparing Flexitouch Home Maintenance Therapy to Standard Home Maintenance Therapy for Lower Extremity Lymphedema Resulting From Treatment of Gynecologic Malignancy
- 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)
This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how well it works compared with standard home maintenance therapy in treating patients with lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or endometrial cancer. Flexitouch® home maintenance therapy may lessen lower-extremity lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the Flexitouch® system is more effective than standard home maintenance therapy in treating lymphedema.
Conditions
Conditions (19)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
| Stage 0 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage 0 Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage 0 Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_BROADER | 0.78 |
| Stage IA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Management of Therapy Complications | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.
- interventionNames
- Procedure: Management of Therapy Complications
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks
- interventionNames
- Procedure: Management of Therapy Complications
- Other: Quality-of-Life Assessment
Primary outcomes (1)
- measure
- Lower-extremity Volumes for Both Unaffected and Affected Legs
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Criteria: * Has lower-extremity lymphedema on one side of the body caused by surgery, chemotherapy, and/or radiation therapy. * At least 6 months since clinic therapy for lower-extremity lymphedema * Is within 3 years from finishing cancer treatment * No active or recurrent cancer * More than 3 months since cancer treatment
References
Publications (0)
Data not yet available