Clinical trial · Interventional
Home-based Compression Therapy for Arm and Truncal Lymphedema in 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)
No studies have tested the potential benefit of the Flexitouch® truncal/chest garments on reducing truncal lymphedema in breast cancer survivors (BCS) or the theoretical added benefit of applying truncal/chest pneumatic compression therapy to open lymph channels in individuals who have only limb lymphedema or its impact on the trunk/chest. The purpose of this two-part study is to fill gaps related to: 1) the impact of the Flexitouch® System on truncal lymphedema, and 2) the therapeutic benefit of truncal /chest pneumatic compression therapy for arm lymphedema. Hypotheses: Part One: BCS with arm and truncal lymphedema. H1: Arm swelling (as measured by bioelectrical impedance \& arm girth in cm) will be reduced after 10 sessions with the Flexitouch® System. H2: Truncal swelling (as measured circumferentially) will be reduced after 10 sessions with the Flexitouch® System. H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by the Lymphedema Symptom Intensity and Distress Scale: Trunk and Arm) will be reduced after 10 sessions with the Flexitouch® System. H4: Functional assessment scores (as measured by the Functional Assessment Screening Questionnaire \[FASQ\] will improve after 10 sessions with the Flexitouch® System. Part Two: BCS with Arm Lymphedema H1: Arm volume (as measured by bioelectrical impedance \& arm girth in cm) will be significantly reduced after one month of home use in participants using the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only). H2: Truncal measurements/volume (as measured circumferentially) will be less after one month of home use with the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only). H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by Lymphedema Symptom Intensity and Distress Scale - Arm ) will be significantly reduced after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only) . H4: Functional assessment scores (as measured by the FASQ) will be significantly higher after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arm Lymphedema | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Truncal Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flexitouch System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- arm compression only
- description
- Intervention of arm compression only by Flexitouch System
- interventionNames
- Device: Flexitouch System
- type
- EXPERIMENTAL
- label
- arm, trunk and chest compression
- description
- Intervention of arm, trunk and chest compression by Flexitouch System
- interventionNames
- Device: Flexitouch System
Primary outcomes (1)
- measure
- Arm Volume at End of Study
- timeFrame
- end of scheduled treatments-day 30 of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Individuals at least six months post- surgery and/or radiation treatment for breast cancer 2. At least 21 years of age 3. Lymphedema in one arm subsequent to breast cancer treatment with coexisting truncal swelling \*\* (Part One) and \*lymphedema in one arm subsequent to breast cancer treatment without coexisting truncal swelling (Part Two) 4. Willing and able to drive to the study site as needed 5. Currently not using a compression pump or undergoing manual lymphatic drainage by a therapist Exclusion Criteria: 1. Actively undergoing or less than six months post intravenous chemotherapy or radiation therapy 2. Individuals with congestive heart failure, chronic/acute renal disease, cor pulmonal, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, thrombophlebitis, deep vein thrombosis, infection of any kind and inflammation (redness) in the trunk or arms 3. History of bilateral breast cancer 4. Metastatic cancer 5. Inability to stand upright 6. Metal implants that would interfere with bioimpedance measurement equipment 7. Pregnancy 8. Pacemaker and internally implanted defibrillators
References
Publications (2)
- RESULTRidner SH, Murphy B, Deng J, Kidd N, Galford E, Dietrich MS. Advanced pneumatic therapy in self-care of chronic lymphedema of the trunk. Lymphat Res Biol. 2010 Dec;8(4):209-15. doi: 10.1089/lrb.2010.0010. PMID 21190493
- RESULTRidner SH, Murphy B, Deng J, Kidd N, Galford E, Bonner C, Bond SM, Dietrich MS. A randomized clinical trial comparing advanced pneumatic truncal, chest, and arm treatment to arm treatment only in self-care of arm lymphedema. Breast Cancer Res Treat. 2012 Jan;131(1):147-58. doi: 10.1007/s10549-011-1795-5. Epub 2011 Sep 30. PMID 21960113