Clinical trial · Observational
Screening For BCRL In Targeted Therapy For Breast Cancer
Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
NCT05142800CI-TRIAL-00117776recruitingClinicalTrials.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)
This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer. A Perometer and Sozo devise will be used to measure volume changes
Conditions
Conditions (11)
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 |
| Breast Cancer Lymphedema | — | UNRESOLVED | — |
| Breast Cancer Metastatic | — | UNRESOLVED | — |
| Breast Cancer Stage | — | UNRESOLVED | — |
| Edema | — | UNRESOLVED | — |
| Edema Arm | — | UNRESOLVED | — |
| Lymphedema | — | UNRESOLVED | — |
| Lymphedema Arm | — | UNRESOLVED | — |
| Lymphedema of the Hands | — | UNRESOLVED | — |
| Lymphedema of Upper Arm | — | UNRESOLVED | — |
| Lymphedema of Upper Limb | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Perometer | Device | — | UNRESOLVED |
| SOZO device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Target Therapy Drug-Stand Care
- description
- Screening procedures confirm participation in the research study. * Participants limb volume is measured prior to treatment start date. * Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card. * Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication
- interventionNames
- Device: Perometer
- Device: SOZO device
- label
- Target Therapy-Early or Metastatic Breast Cancer
- description
- Screening procedures confirm participation in the research study. * Participants limb volume is measured prior to treatment start date. * Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card. * Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication
- interventionNames
- Device: Perometer
- Device: SOZO device
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF/HCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible. * Subjects that will be eligible for the study include: * Females between 18 and 80 years of age * With a history of breast cancer * 4 weeks or more post-surgery * With or without edema * Undergoing treatment with targeted therapy for early or metastatic disease. Exclusion Criteria: \- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).
References
Publications (0)
Data not yet available
No reference posted for this study.