Clinical trial · Interventional
Flexitouch Lymphedema System in Treating Stage II Lymphedema in Patients With Breast Cancer
A Pilot, Randomized, Single-Blind Study to Assess the Efficacy of the Flexitouch® Lymphedema System in Reducing Lymphedema in Patients Treated for Breast Cancer
- 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)
RATIONALE: The Flexitouch lymphedema system may lessen lymphedema caused by treatment for breast cancer. It is not yet known whether the Flexitouch lymphedema system is more effective than complex decongestive therapy in treating lymphedema. PURPOSE: This randomized clinical trial is studying the Flexitouch lymphedema system in treating stage II lymphedema in patients with breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lymphedema management | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients undergo complex decongestive therapy comprising daily compression garment (sleeve and glove) use, daily manual lymphatic drainage (self-administerd), and nighttime bandaging with low stretch Comprilan bandages.
- interventionNames
- Other: questionnaire administration
- Other: lymphedema management
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients undergo daily compression with garments (sleeve and glove), nighttime bandaging with low stretch Comprilan bandages, and daily Flexitouch treatment over 1 hour every evening.
- interventionNames
- Other: questionnaire administration
- Other: lymphedema management
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion * Subjects must have a known, clinical diagnosis of stage II lymphedema as verified by a physician specializing in this disorder * Subjects must have had a unilateral mastectomy, lymph node (LN) dissection and/or radiation therapy for the treatment of primary breast cancer * Subjects must have completed their course of adjuvant chemotherapy * Clinical assessment of lymphedema demonstrating at least 10% difference between the volumes of the affected and opposite limbs at the time of enrollment * Subjects must be completing phase I of their CDT for their initial onset of lymphedema or for an acute flare of lymphedema * Subjects must be capable of giving informed consent Exclusion * History of prior trauma and/or surgery in the affected limb other than that for treatment of breast cancer * Patients with recurrent breast cancer * History of bilateral breast cancer * Subjects currently receiving other therapies for lymphedema * Subjects with renal, liver, and/or heart dysfunction * Open wounds or web syndrome * Active/acute infection (cellulitis) * Acute DVT/Thrombophlebitis * Decompensated or untreated congestive heart failure * Pulmonary embolism - Pregnancy as confirmed by urine test; all patients of child bearing potential will be required to have a urine pregnancy test * Subjects cannot be homeless persons * Concomitant chemotherapy and radiation treatment during this study is not permitted
References
Publications (0)
Data not yet available