Clinical trial · Interventional
Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
NCT00383500CI-TRIAL-00026698completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
To compare the effectiveness of usual treatments for lymphedema \[massage and elastic compression sleeve, instituted at-risk and before the development of swelling (lymphedema)\], compared to the use of a newly-marketed device, the Flexitouch, which electronically simulates the effect of massage upon lymph flow.
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 |
|---|---|---|---|
| Class 1 compression garment | Device | — | UNRESOLVED |
| Flexitouch | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Flexitouch device
- description
- Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)
- interventionNames
- Device: Flexitouch
- type
- EXPERIMENTAL
- label
- Manual Lymphatic Drainage (MLD)
- description
- Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment
- interventionNames
- Device: Class 1 compression garment
- type
- NO_INTERVENTION
- label
- Observational Control (no intervention)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unilateral breast cancer * Scheduled to undergo breast surgery and axillary lymph node dissection, with or without breast conserving techniques. * Referred to the surgeons of the Stanford University Breast Cancer Program * Capacity to provide informed consent. * All experimental protocols will be reviewed and approved by the Stanford Institutional Review Board for the Protection of Human Subjects. Exclusion Criteria: * Other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate. * Recurrent breast cancer or other forms of pre-existing lymphedema.
References
Publications (0)
Data not yet available
No reference posted for this study.