Clinical trial · Interventional
Bioimpedance Spectroscopy Versus Tape Measure in Prevention of Lymphedema (PREVENT)
A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement in the Prevention of Lymphedema Following Locoregional Treatment for Breast Cancer (PREVENT)
NCT02167659CI-TRIAL-00049341completedN/AClinicalTrials.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)
Based upon the current state of science, the investigators are proposing to conduct a randomized clinical trial in which participants are randomized post-surgery to either BIS or circumferential (tape) measurements for follow-up arm measurements. When patients in the BIS group have an L-Dex change that is ≥6.5 units higher than the pre-surgical baseline measure, and when patients in the tape measurement group have a volume change in the at-risk arm that is between ≥ 5% and \<10% above pre-surgical baselines (without similar change in non-at-risk arm), both will receive four weeks of 23-32 mm compression sleeve and gauntlet therapy.
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 |
|---|---|---|---|
| 23-32 mmHg compression sleeve with gauntlet | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BIS Assessment
- description
- Patients will undergo measurements by trained staff. Measurements will be performed pre-op and at 3, 6, 12, 15\*, 18, 21\*, 24, and 36 months post-op. Measures include L-Dex, skin assessment and self-report forms. Patients with \< 6.5 L-Dex units change will continue follow-up for 36 months. Patients with an L-Dex value change ≥ 6.5 will undergo circumference measurement and begin treatment for 4 weeks with a 23-32 mmHg compression sleeve with gauntlet. At the end of 4 weeks patients will have their arms measured. Those demonstrating improvement will continue with follow up. Those not demonstrating improvement will be removed from the study and their medical oncologist or surgeon will be notified. \*At discretion of the site PI or attending physicians.
- interventionNames
- Device: 23-32 mmHg compression sleeve with gauntlet
- type
- ACTIVE_COMPARATOR
- label
- Tape Measure
- description
- Patients will undergo measurements by trained staff. Measurements will be performed pre-op and at 3, 6, 12, 15\*, 18, 21\*, 24, and 36 months post-op. Measures include arm volume (tape measure), skin assessment and self-report forms. Patients with no volume increase will continue follow-up for 36 months. Patients with a volume change of between ≥ 5% and \< 10% in the at-risk limb will undergo L-Dex testing and begin treatment for 4 weeks with a 23-32 mmHg compression sleeve with gauntlet. At the end of 4 weeks patients will have their arms measured. Those demonstrating improvement will continue with follow up. Those not demonstrating improvement will be removed from the study and their medical oncologist or surgeon will be notified. \*At discretion of the site PI or attending physicians.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed invasive breast cancer or Ductal Carcinoma In Situ (DCIS) * Planned surgical procedure * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Prior history of breast cancer, breast/chest wall/axillary radiation therapy * Definitive breast surgical procedure prior to enrollment. * Active implanted medical device (e.g., cardiac pacemakers, defibrillators) or patients connected to electronic life support devices or metallic devices that would interfere with BIS measurements. * Conditions that could cause swelling (e.g., pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis, or deep vein thrombosis in arms * Previous treatment for lymphedema of either arm. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or cardiac arrhythmia. * Psychiatric illness (e.g., diagnosed schizophrenia or documented dementia) that would limit compliance with study requirements. * Known allergy to electrode adhesives or woven knit compression fabrics * Bilateral breast cancer or planned bilateral mastectomy
References
Publications (3)
- DERIVEDBoyages J, Vicini FA, Manavi BA, Gaw RL, Koelmeyer LA, Ridner SH, Shah C. Axillary Treatment and Chronic Breast Cancer-Related Lymphedema: Implications for Prospective Surveillance and Intervention From a Randomized Controlled Trial. JCO Oncol Pract. 2023 Dec;19(12):1116-1124. doi: 10.1200/OP.23.00060. Epub 2023 Oct 10. PMID 37816208
- DERIVEDDietrich MS, Gaitatzis K, Koelmeyer L, Boyages J, Abramson VG, McLaughlin SA, Ngui N, Elder E, French J, Hsu J, Hughes TM, Stolldorf DP, Shah C, Ridner SH. Prospective Surveillance with Compression for Subclinical Lymphedema: Symptoms, Skin, and Quality-of-Life Outcomes. Lymphat Res Biol. 2023 Jun;21(3):304-313. doi: 10.1089/lrb.2022.0020. Epub 2022 Sep 20. PMID 36126315
- DERIVEDRidner SH, Dietrich MS, Boyages J, Koelmeyer L, Elder E, Hughes TM, French J, Ngui N, Hsu J, Abramson VG, Moore A, Shah C. A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. Lymphat Res Biol. 2022 Dec;20(6):618-628. doi: 10.1089/lrb.2021.0084. Epub 2022 Jan 28. PMID 35099283