Clinical trial NCT00845078: Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
Official title: Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast
Radiotherapy
Aesthetics
Treatment Outcome
Surgical Reconstruction
Keywords: Breast
Radiotherapy
Esthetics
Treatment Outcome
Reconstructive Surgical Procedures
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing mastectomy and radiation for breast cancer, who desire breast reconstruction after mastectomy

Brief summary: 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.

Detailed description: Neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer treatment. (1, 2) Administration of radiation before or after autologous soft tissue reconstruction has being shown to alter the aesthetics of the new breast. (3-7) Currently, the optimal timing for autologous breast reconstruction in patients who need postmastectomy radiotherapy remains in debate between surgeons. (8) Various studies have tried to address this problem. However, most of them have been retrospective studies (3, 7, 9) and the prospective ones have not have enough patients, have mixed population of patients or the radiation protocols have not been normalized. (5, 6, 10)

We 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.

Eligibility criteria: 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

Primary outcomes:
measure: Aesthetic breast scores
timeFrame: preoperative, 1 month, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Quality of life (SF36)
timeFrame: preoperative, 1 month, 6 months, 12 months, 24 months
measure: Patient Breast aesthetic perception (BR23)
timeFrame: preoperative, 1 month, 6 months, 12 months, 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Julio A Clavijo-Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Michael L Gimbel, MD
role: STUDY_DIRECTOR
References:
citation: Edsander-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.
citation: Tran 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.
citation: Tran 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.
citation: Kroll 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.
citation: Kroll 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.