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Delayed-Delayed Breast Reconstruction

14 juillet 2016 mis à jour par: 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Texas
      • Houston, Texas, États-Unis, 77030
        • University of Texas MD Anderson Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Procédure: 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall Complication Rate
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

M.D. Anderson Cancer Center

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2010

Achèvement primaire (Réel)

1 septembre 2015

Achèvement de l'étude (Réel)

1 septembre 2015

Dates d'inscription aux études

Première soumission

7 décembre 2010

Première soumission répondant aux critères de contrôle qualité

7 décembre 2010

Première publication (Estimation)

8 décembre 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

15 juillet 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juillet 2016

Dernière vérification

1 juillet 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2010-0053
  • NCI-2011-00270 (Identificateur de registre: NCI CTRP)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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