Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients
A Multi-center Prospective Observational Trial Investigating the Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Anticipato)
Iscrizione
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Shanshan He
- Numero di telefono: 1174 +86-22-23340123
- Email: ssh85@yahoo.com
Backup dei contatti dello studio
- Nome: Jian Yin
- Numero di telefono: 1171 +86-22-23340123
- Email: yinjian@tjmuch.com
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Diagnosed with breast cancer
- Karnofsky Performance Status (KPS) larger than 70
- Underwent autologous or prosthetic based breast reconstruction
- No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
Exclusion Criteria:
- Metastatic breast cancer
- Local recurrence after mastectomy
- Prior radiation history to chest wall due to other tumors
- Radiation performed more than 6 months after mastectomy
- Interruption of radiation more than 2 weeks
- Gravida or during lactation
- Concurrently undergoing psychotic disorders
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Numero di gruppi/coorti
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
BR group
Breast reconstruction without radiation therapy
|
Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
|
|
Immediate BR +post-op radiation
Immediate breast reconstruction followed by surgical site radiation therapy
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Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy
|
|
Radiation +delayed BR
previous post-mastectomy radiation followed by delayed breast reconstruction
|
Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
occurrence of short term complications
Lasso di tempo: the short term complications will be inspected up to 3 months post-op;
|
impaired arterial or venous flap perfusion by increased (>3 seconds) or reduced (<2 seconds) capillary refill time; infection of the reconstructed breast with evidences from microbiological cultures; partial or entire flap necrosis with evident demarcation by clinical observation
|
the short term complications will be inspected up to 3 months post-op;
|
|
occurrence and change of long term complications
Lasso di tempo: the long term complications will be assessed at 6 months post-op; repeated assessments will be made at 12 and 24 months to record changes
|
fat necrosis proven by breast ultrasound/ breast MRI/ pathology; flap contracture that causes change in shape and/or volume in the reconstructed breast mound observed by naked-eye inspection or breast imaging; capsular contracture that causes hardness/pains or changes of the reconstructed breast mound observed by surgeon's inspection or breast imaging.
|
the long term complications will be assessed at 6 months post-op; repeated assessments will be made at 12 and 24 months to record changes
|
|
occurrence of secondary surgery
Lasso di tempo: up to 24 months post-op
|
unplanned surgery due to short-term and/or long-term complications post-op, the types of secondary surgery include but not limited to exploratory surgery, flap salvages, removal or fat necrosis, debridement, prosthetic explantation.
|
up to 24 months post-op
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
occurrence of revision surgery
Lasso di tempo: 6 to 24 months post-op
|
any surgery performed to the reconstructed or contralateral breast to optimize symmetry
|
6 to 24 months post-op
|
|
baseline and change of subjective evaluation
Lasso di tempo: the baseline evaluation will be made at 6 months post-op; repeated evaluations will be made at 12 and 24 months to record changes
|
patient oriented aesthetic, psychological and overall outcome evaluations are made with BREAST-Q (short for breast-questionnaire) post reconstruction module, the the selected questionnaire includes a set of questions regarding : category 1-patients' satisfaction with breasts; category 2-patients' satisfaction with outcome and category 3-patients' psychological well-being.
In each category, the total score is generated by Q-score (short for questionnaire-score)software and the total score ranges from 0-100.
The higher the score the better the satisfaction.
|
the baseline evaluation will be made at 6 months post-op; repeated evaluations will be made at 12 and 24 months to record changes
|
Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Jian Yin, Tianjin Medical University Cancer Institute and Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20.
- Schaverien MV, Macmillan RD, McCulley SJ. Is immediate autologous breast reconstruction with postoperative radiotherapy good practice?: a systematic review of the literature. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1637-51. doi: 10.1016/j.bjps.2013.06.059. Epub 2013 Jul 22.
- Berbers J, van Baardwijk A, Houben R, Heuts E, Smidt M, Keymeulen K, Bessems M, Tuinder S, Boersma LJ. 'Reconstruction: before or after postmastectomy radiotherapy?' A systematic review of the literature. Eur J Cancer. 2014 Nov;50(16):2752-62. doi: 10.1016/j.ejca.2014.07.023. Epub 2014 Aug 26.
- Kelley BP, Ahmed R, Kidwell KM, Kozlow JH, Chung KC, Momoh AO. A systematic review of morbidity associated with autologous breast reconstruction before and after exposure to radiotherapy: are current practices ideal? Ann Surg Oncol. 2014 May;21(5):1732-8. doi: 10.1245/s10434-014-3494-z. Epub 2014 Jan 29.
- Losken A, Nicholas CS, Pinell XA, Carlson GW. Outcomes evaluation following bilateral breast reconstruction using latissimus dorsi myocutaneous flaps. Ann Plast Surg. 2010 Jul;65(1):17-22. doi: 10.1097/SAP.0b013e3181bda349.
- Selber JC, Kurichi JE, Vega SJ, Sonnad SS, Serletti JM. Risk factors and complications in free TRAM flap breast reconstruction. Ann Plast Surg. 2006 May;56(5):492-7. doi: 10.1097/01.sap.0000210180.72721.4a.
- Chang EI, Liu TS, Festekjian JH, Da Lio AL, Crisera CA. Effects of radiation therapy for breast cancer based on type of free flap reconstruction. Plast Reconstr Surg. 2013 Jan;131(1):1e-8e. doi: 10.1097/PRS.0b013e3182729d33.
- Kronowitz SJ. Current status of implant-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2012 Oct;130(4):513e-523e. doi: 10.1097/PRS.0b013e318262f059.
- Pestana IA, Campbell DC, Bharti G, Thompson JT. Factors affecting complications in radiated breast reconstruction. Ann Plast Surg. 2013 May;70(5):542-5. doi: 10.1097/SAP.0b013e31827eacff.
- Chatterjee JS, Lee A, Anderson W, Baker L, Stevenson JH, Dewar JA, Thompson AM. Effect of postoperative radiotherapy on autologous deep inferior epigastric perforator flap volume after immediate breast reconstruction. Br J Surg. 2009 Oct;96(10):1135-40. doi: 10.1002/bjs.6693.
- Rogers NE, Allen RJ. Radiation effects on breast reconstruction with the deep inferior epigastric perforator flap. Plast Reconstr Surg. 2002 May;109(6):1919-24; discussion 1925-6. doi: 10.1097/00006534-200205000-00022.
- Yueh JH, Slavin SA, Adesiyun T, Nyame TT, Gautam S, Morris DJ, Tobias AM, Lee BT. Patient satisfaction in postmastectomy breast reconstruction: a comparative evaluation of DIEP, TRAM, latissimus flap, and implant techniques. Plast Reconstr Surg. 2010 Jun;125(6):1585-1595. doi: 10.1097/PRS.0b013e3181cb6351.
- Lam TC, Hsieh F, Boyages J. The effects of postmastectomy adjuvant radiotherapy on immediate two-stage prosthetic breast reconstruction: a systematic review. Plast Reconstr Surg. 2013 Sep;132(3):511-518. doi: 10.1097/PRS.0b013e31829acc41.
- He S, Yin J, Robb GL, Sun J, Zhang X, Li H, Liu J, Han C. Considering the Optimal Timing of Breast Reconstruction With Abdominal Flaps With Adjuvant Irradiation in 370 Consecutive Pedicled Transverse Rectus Abdominis Myocutaneous Flap and Free Deep Inferior Epigastric Perforator Flap Performed in a Chinese Oncology Center: Is There a Significant Difference Between Immediate and Delayed? Ann Plast Surg. 2017 Jun;78(6):633-640. doi: 10.1097/SAP.0000000000000927.
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- E2018210
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