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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

The purpose of the study is to investigate the impacts of radiation and the timing of radiation on autologous and prosthetic-based breast reconstruction in Chinese post-mastectomy breast cancer patients. The study aims to optimize the timing for autologous/prosthetic breast reconstruction which delivers the best aesthetic results while maintains low complication rate and best integrates into the comprehensive breast cancer treatment. The study is open to all female breast cancer patients undergoing breast reconstruction in the department of breast reconstruction in Tianjin medical university cancer institute and hospital.

Aperçu de l'étude

Description détaillée

In breast cancer patients, post-operative radiation therapy is an important component in breast cancer management. However, in the context of breast reconstruction, radiation can have adverse effect as it increases the rate of fat necrosis and leads to fibrosis/ capsular contracture in the reconstructed breast mounds. It is therefore necessary to investigate the best timing for breast reconstruction, especially in those patients which post-operative radiation is required, which does not interfere with overall breast cancer treatment while produces the best surgical, aesthetic and psychological outcome. Most studies in this field are retrospective, and studies on Chinese cohort are also rare. This multi-center prospectively designed clinical trial will include several medical centers across China. The investigators will allocate the patients into three arms based on the status and sequence of radiation and breast reconstruction, and will further stratify the groups based on the different approaches of reconstruction (autologous/ prosthetic based). Both objective and subjective (patient oriented) methods will be employed to make evaluations involving surgical, aesthetic, and psychological outcomes.

Type d'étude

Observationnel

Inscription (Anticipé)

1344

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.

Coordonnées de l'étude

  • Nom: Shanshan He
  • Numéro de téléphone: 1174 +86-22-23340123
  • E-mail: ssh85@yahoo.com

Sauvegarde des contacts de l'étude

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

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Study population include female Chinese breast cancer patients who wish to undergo autologous or prosthetic-based breast reconstruction.

La description

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

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

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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
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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
occurrence of short term complications
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
occurrence of revision surgery
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Chercheur principal: Jian Yin, Tianjin Medical University Cancer Institute and Hospital

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.

Publications générales

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 (Anticipé)

1 janvier 2019

Achèvement primaire (Anticipé)

1 novembre 2022

Achèvement de l'étude (Anticipé)

1 avril 2023

Dates d'inscription aux études

Première soumission

7 novembre 2018

Première soumission répondant aux critères de contrôle qualité

14 novembre 2018

Première publication (Réel)

16 novembre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 novembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 novembre 2018

Dernière vérification

1 novembre 2018

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • E2018210

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

There is no plan to share IPD with other researchers.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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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