Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

NCT00845078 | Withdrawn

• 1 other identifier: PRO07120002
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast; Radiotherapy; Aesthetics; Treatment Outcome; Surgical Reconstruction

Keywords

Breast; Radiotherapy; Esthetics; Treatment Outcome; Reconstructive Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• Aesthetic breast scores

  preoperative, 1 month, 6 months, 12 months, 24 months

Secondary Outcomes (2)

• Quality of life (SF36)

  preoperative, 1 month, 6 months, 12 months, 24 months

• Patient Breast aesthetic perception (BR23)

  preoperative, 1 month, 6 months, 12 months, 24 months

Study Arms (2)

1

Immediate reconstruction followed by radiation therapy

2

Radiation therapy followed by delayed reconstruction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing mastectomy and radiation for breast cancer, who desire breast reconstruction after mastectomy

You may qualify if:

• Breast cancer requiring mastectomy and post-mastectomy radiation
• Desire for breast reconstruction after mastectomy

You may not qualify if:

• Inflammatory breast cancer
• Age \< 18 years old
• No desire for breast reconstruction
• Women without need for postmastectomy radiation

Sponsors & Collaborators

• University of Pittsburgh: lead

Related Publications (5)

• 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.

  PMID: 11373553 BACKGROUND

• 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.

  PMID: 11420508 RESULT

• 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.

  PMID: 10946929 RESULT

• 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.

  PMID: 9618094 RESULT

• 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.

  PMID: 7652060 RESULT

Study Officials

• Julio A Clavijo-Alvarez, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Michael L Gimbel, MD

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: December 1, 2008
• Last Updated: April 27, 2017

Record last verified: 2009-02