Clinical trial · Interventional
Pilot Study Assessing Breast Temperature in Breast Cancer Patients
Pilot Study Assessing Cutaneous Breast Temperature in the Setting of Mastectomy and Reconstruction
NCT03376035CI-TRIAL-00036400completedN/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)
Our investigators plan to measure the skin on the breast six months after breast reconstruction. The non-reconstructed breast will be used as the control for subject with unilateral reconstruction only. For those who have BILATERAL reconstruction, a core temperature will be obtained from the ear.
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 |
|---|---|---|---|
| Breast Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temperature measurement of breast | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Unilateral breast reconstruction
- description
- Temperature measurements are obtained from the reconstructed breast and compared to the non-reconstructed breast.
- interventionNames
- Other: Temperature measurement of breast
- type
- EXPERIMENTAL
- label
- Bilateral breast reconstruction
- description
- Temperature measurements are obtained from both reconstructed breasts and the core temperature is measured as well for comparison.
- interventionNames
- Other: Temperature measurement of breast
Primary outcomes (1)
- measure
- Change in skin temperature after breast reconstruction
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * For post-reconstruction patients: all patients who have undergone mastectomy and breast reconstruction at Duke and are seen in clinic no sooner than 3 months after reconstruction and no more than 5 years after reconstruction. Exclusion Criteria: * Metastatic malignancy of any kind. * Subjects with a history of breast implant augmentation prior to mastectomy and reconstruction. * Subjects who cannot give an informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.