Clinical trial · Interventional
Bioelectrical Impedance for Self-monitoring of Lymphedema
Bioelectrical Impedance for Self-monitoring of Breast Cancer Related 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)
* Breast cancer treatment-related lymphedema requires life-long self-care is required. * No objective measurement mechanism exists that can easily be used to self-monitor arm volume. * Bioelectrical impedance devices approved for lymphedema measurement may be able to be used for self-monitoring. * The investigators will conduct a two-part study to first develop an impedance driven self-measurement protocal and then test the protocol in home settings. * The investigators hypothesize in part two of the study that when compared to participants who are not self-monitoring, those who self-monitor limb volume will: 1) report more days of garment use, skin care, and simple-MLD; and, 2) have fewer, less distressful, less intense symptoms, better productivity/activity, report higher perceived self-management/self-efficacy and QOL; experience fewer missed days of work, lymphedema treatment days, arm infections, and have a smaller number of antibiotic prescriptions.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| self-monitor arm volume | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- self-monitoring
- description
- participants will use bioelectrical impedance to self-monitor arm volume at home
- interventionNames
- Behavioral: self-monitor arm volume
- type
- NO_INTERVENTION
- label
- completion of forms
- description
- participants will complete self-report forms
Primary outcomes (2)
- measure
- self care behaviors
- timeFrame
- 4 months
- description
- individual tasks initiated by a participant to care for their lymphedema that may vary from participant to participant.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Healthy Volunteers for Phase 1: no known history of cancer or lymphatic disease. 2. Lymphedema volunteers Phases 1 \&2: history of breast cancer and diagnosis of lymphedema in one arm. 3. All volunteers: ≥ 21 years of age. Exclusion Criteria: 1. Healthy Volunteers Phase 1: history of arm surgery or family history of primary lymphedema. 2. Lymphedema volunteers Phases 1 \& 2: bilateral lymphedema. 3. All volunteers: * inability to stand upright; * conditions that could cause swelling: pregnancy, congestive heart failure, liver failure; * infection, open sores on arms, or known sensitivity to electrodes; * pacemakers or internal defibrillators; * currently undergoing IV chemotherapy or radiation; or * use of laxatives or diuretics to lose weight.
References
Publications (0)
Data not yet available