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Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients

14 de noviembre de 2018 actualizado por: Tianjin Medical University Cancer Institute and Hospital

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Anticipado)

1344

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Shanshan He
  • Número de teléfono: 1174 +86-22-23340123
  • Correo electrónico: ssh85@yahoo.com

Copia de seguridad de contactos de estudio

  • Nombre: Jian Yin
  • Número de teléfono: 1171 +86-22-23340123
  • Correo electrónico: yinjian@tjmuch.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
occurrence of short term complications
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
occurrence of revision surgery
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de enero de 2019

Finalización primaria (Anticipado)

1 de noviembre de 2022

Finalización del estudio (Anticipado)

1 de abril de 2023

Fechas de registro del estudio

Enviado por primera vez

7 de noviembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

14 de noviembre de 2018

Publicado por primera vez (Actual)

16 de noviembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de noviembre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

14 de noviembre de 2018

Última verificación

1 de noviembre de 2018

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • E2018210

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

There is no plan to share IPD with other researchers.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Cáncer de mama

Ensayos clínicos sobre Immediate Breast reconstruction

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