Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Delayed-Delayed Breast Reconstruction

14 juli 2016 uppdaterad av: M.D. Anderson Cancer Center

A Multidisciplinary Protocol for Planned Skin-Preserving Delayed Breast Reconstruction for Patients With Locally Advanced Breast Cancer Requiring Postmastectomy Radiation Therapy

The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the standard approach (reconstruction that is not started until radiation treatment is completed).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Study Visits and Surgeries:

You will be hospitalized 2-4 times for 1-5 days depending on your condition. If you agree to take part in this study, you will be scheduled for a skin-sparing mastectomy. The following tests and procedures will be performed:

Pre-Operative Visit:

  • Your complete medical history will be updated.
  • The doctor will determine what type of reconstructive surgery can be done.
  • You will have photos taken of your breasts. Your face, hair, or jewelry will not be photographed. These photos will be kept in a password-protected computer accessible only by the principle investigator and people directly involved in this study.
  • You will complete a quality of life questionnaire. The questionnaire asks about how satisfied you are with your appearance. The questionnaire will be sent by email, US postal service mail, or in person when you come for your follow up visits. The questionnaire should take about 20 minutes to complete. If sent by US postal service, you will be given a postage-paid envelope to return the questionnaire.

At your Mastectomy Surgery:

  • Your complete medical history will be updated.
  • You will have photos taken of your breasts.
  • During the surgery, a tissue expander will be placed in your breast. Sterile salt water will be added to inflate the expander and a small skin sample (about the size of a pencil eraser) from the breast will be taken to study stretching and scarring of the skin. The tissue will be securely maintained at MD Anderson.
  • You will be monitored for any problems.

Post-Operative Visit - 7 to 10 Days after Mastectomy Surgery:

  • The study staff will look at the results of your surgery.
  • Your complete medical history will be updated.
  • You will complete the quality of life questionnaire.
  • You will be asked about any problems you may be having.

Deflation Visit - Week 5:

  • Your complete medical history will be updated.
  • You will have photos taken of your breasts.
  • The sterile salt water in the expander will be let out, causing the breast to go flat. This is done by inserting a needle into a special port and withdrawing the fluid with a syringe.

Radiation Visit - Week 8:

  • You must have radiation either at M. D. Anderson or an M. D. Anderson-affiliated site.
  • Extra fluid may be added to the tissue expander before radiation.
  • The study staff will look at the results of your surgery.
  • You will be asked about any problems you may be having.
  • You will receive radiation, typically 5 days a week for 6 weeks.

Post-Radiation Visits - About Week 13 and every 2 to 4 Weeks after:

  • Your complete medical history will be updated.
  • The study staff will look at the results of your surgery.
  • You will be asked about any problems you may be having.
  • You will complete the quality of life questionnaire.
  • Your expander will be re-inflated.

Delayed-delayed Reconstruction Surgery - At about Week 23:

  • Your complete medical history will be updated.
  • You will have photos taken of your breasts.
  • During surgery, you will be monitored for any problems. A tissue sample will be collected to study stretching and scarring of the skin from the mastectomy incision and the tissue that is used to form the new breast. The tissue will be securely maintained at MD Anderson.
  • During surgery, you will have tissue moved from your lower abdomen, back, or buttock to be used for reconstruction. A silicone or saline breast implant may or may not be used to help construct the breast. The amount of tissue used for building the breast will depend on your body size and donation site. Your reconstructive surgeon will discuss this with you before surgery.
  • During surgery, the expander will be removed and reconstruction of your breast will occur.

Follow-Up Surgery - At about Week 47:

  • Your complete medical history will be updated.
  • You will have photos taken of your breasts.
  • You will complete the quality of life questionnaire.
  • During surgery, you will be monitored for any problems and a tissue sample will be collected.
  • During this surgery, procedures will be done to improve the appearance of the breast.

Long-Term Follow-Up Visits - At 6, 12, 24, and 36 Months:

  • Your complete medical history will be updated.
  • You will have photos taken of your breasts.
  • You will be asked about any problems you may be having.
  • At Months 12 and 24, you will complete the quality of life questionnaire.

This is an investigational study. The implants in this study have been FDA approved for skin expansion as a method of breast reconstruction. The use of the implants is investigational in this study.

Up to 200 women will take part in this study. All will be enrolled at M. D. Anderson.

Studietyp

Interventionell

Inskrivning (Faktisk)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • University of Texas MD Anderson Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  1. Patients with invasive breast carcinoma that are scheduled for a mastectomy with planned postmastectomy XRT. This includes, but is not limited to, clinical stage II, III, and IV.
  2. Patient must desire breast reconstruction.
  3. Patients must sign the informed consent form and must be deemed by operative surgeon not to have medical contraindications for delayed-delayed approach.
  4. Patients must be 18 years of age or older.

Exclusion Criteria:

  1. Patients in whom it is not known preoperatively to need postmastectomy radiation therapy.
  2. Patients with inflammatory breast cancer.
  3. Patients in whom the breast skin can not be spared because of involvement with breast cancer.
  4. Any patient deemed by the radiation oncologist during preoperative consultation to be an inappropriate patient for this protocol.
  5. Patients that can not commit to receiving postmastectomy radiation treatment in addition to breast reconstructive procedures at MD Anderson Cancer Center or satellite affiliates.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Delayed Breast Reconstruction
Approximately 3 months after postmastectomy radiation therapy, the preserved, irradiated, and re-inflated breast skin will be used to perform the delayed breast reconstruction. During the stage 2 reconstruction, the implant or expander will be removed and the definitive reconstruction will be performed with the preserved breast skin utilizing a preference for autologous tissue or autologous tissue with an implant due to the potential for complications with implant-based reconstructions after radiation therapy (XRT).
Procedur: Delayed Breast Reconstruction
Approximately 3 months after postmastectomy radiation therapy, the preserved, irradiated, and re-inflated breast skin will be used to perform the delayed breast reconstruction. During the stage 2 reconstruction, the implant or expander will be removed and the definitive reconstruction will be performed with the preserved breast skin utilizing a preference for autologous tissue or autologous tissue with an implant due to the potential for complications with implant-based reconstructions after radiation therapy (XRT).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Complication Rate
Tidsram: 6 months
Overall complication defined as any of the following complications post breast reconstruction surgery: seroma, hematoma, wound dehiscence, partial flap loss, total flap loss, infection, flap microvascular thrombosis (arterial or venous), venous congestion of flap, flap fat necrosis, mastectomy skin flap necrosis, exposure breast implant, capsular contracture, and delayed wound healing.
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

M.D. Anderson Cancer Center

Utredare

  • Huvudutredare: Steven J. Kronowitz, MD, M.D. Anderson Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2010

Primärt slutförande (Faktisk)

1 september 2015

Avslutad studie (Faktisk)

1 september 2015

Studieregistreringsdatum

Först inskickad

7 december 2010

Först inskickad som uppfyllde QC-kriterierna

7 december 2010

Första postat (Uppskatta)

8 december 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

15 juli 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 juli 2016

Senast verifierad

1 juli 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2010-0053
  • NCI-2011-00270 (Registeridentifierare: NCI CTRP)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera