Clinical trial · Observational
Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
- 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 study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study. The investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aesthetics | — | UNRESOLVED | — |
| Breast | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
| Surgical Reconstruction | — | UNRESOLVED | — |
| Treatment Outcome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- Immediate reconstruction followed by radiation therapy
- label
- 2
- description
- Radiation therapy followed by delayed reconstruction
Primary outcomes (1)
- measure
- Aesthetic breast scores
- timeFrame
- preoperative, 1 month, 6 months, 12 months, 24 months
Secondary outcomes (2)
- measure
- Quality of life (SF36)
- timeFrame
- preoperative, 1 month, 6 months, 12 months, 24 months
- measure
- Patient Breast aesthetic perception (BR23)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer requiring mastectomy and post-mastectomy radiation * Desire for breast reconstruction after mastectomy Exclusion Criteria: * Inflammatory breast cancer * Age \< 18 years old * No desire for breast reconstruction * Women without need for postmastectomy radiation
References
Publications (5)
- BACKGROUNDEdsander-Nord A, Brandberg Y, Wickman M. Quality of life, patients' satisfaction, and aesthetic outcome after pedicled or free TRAM flap breast surgery. Plast Reconstr Surg. 2001 Apr 15;107(5):1142-53; discussion 1154-5. doi: 10.1097/00006534-200104150-00007. PMID 11373553
- RESULTTran NV, Chang DW, Gupta A, Kroll SS, Robb GL. Comparison of immediate and delayed free TRAM flap breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2001 Jul;108(1):78-82. doi: 10.1097/00006534-200107000-00013. PMID 11420508
- RESULTTran NV, Evans GR, Kroll SS, Baldwin BJ, Miller MJ, Reece GP, Robb GL. Postoperative adjuvant irradiation: effects on tranverse rectus abdominis muscle flap breast reconstruction. Plast Reconstr Surg. 2000 Aug;106(2):313-7; discussion 318-20. doi: 10.1097/00006534-200008000-00011. PMID 10946929
- RESULTKroll SS, Robb GL, Reece GP, Miller MJ, Evans GR, Baldwin BJ, Wang B, Schusterman MA. Does prior irradiation increase the risk of total or partial free-flap loss? J Reconstr Microsurg. 1998 May;14(4):263-8. doi: 10.1055/s-2007-1000179. PMID 9618094
- RESULTKroll SS, Coffey JA Jr, Winn RJ, Schusterman MA. A comparison of factors affecting aesthetic outcomes of TRAM flap breast reconstructions. Plast Reconstr Surg. 1995 Sep;96(4):860-4. doi: 10.1097/00006534-199509001-00015. PMID 7652060