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Evaluation of Brain Function Before and After Standard Chemotherapy for Early Breast Cancer

30 de agosto de 2010 actualizado por: National University Hospital, Singapore

Primary Objective

  • To investigate and clearly document the presence and extent of cognitive decline, if any, in women of Asian origin following standard-dose systematic adjuvant chemotherapy for the treatment of breast cancer
  • Investigation and establishment of a relationship between degree of oxidative DNA and lipid damage as indicated by plasma and urinary biochemical markers.

Secondary Objective

• To validate the use of hydrogen peroxide and serum amyloid as biomarkers of damage

Descripción general del estudio

Estado

Terminado

Descripción detallada

As the survival rate and prognosis of cancer improve, there is increasing recognition of the presence of a long term negative impact of standard chemotherapy on cognition, namely in the domains of attention, memory, psychomotor speed and executive functions. The purported incidence varies between 10-50%, the mechanism is unknown and it is unclear who is at risk. This impact has also not been studied and documented in the Asian population.

This proposal outlines a study that intends to prospectively (1) investigate and document the incidence and severity of cognitive impairment following systemic chemotherapy for breast cancer in Asian women in the acute and prolonged setting, and (2) to relate these cognitive changes to damage to DNA and lipids (two major targets of attack by toxic agents) as indicated through tests conducted on blood and urine samples.

Thirty breast cancer patients who will be required to undergo standard chemotherapy will be recruited for a pilot study to determine the acceptability of the procedure and to establish the size of the effects under investigation. A 45-minute neurocognitive assessment will be administered at three time points: before commencement of chemotherapy, and at 6 months and 1 year following completion of chemotherapy. Blood and urine samples will be collected just prior to the commencement of chemotherapy, after the first cycle of chemotherapy, and also at 6 months and 1 year post completion of chemotherapy.

It is hypothesized that (1) there will be decrements in performance on the neurocognitive measures post-chemotherapy; (2) the presence of cognitive decline will correlate with the presence of markers of oxidative damage in the blood and urine samples. The benefits of this project are two fold. Firstly, it will allow research into and documentation of the possible presence of cognitive decline following chemotherapy in Asian women, which is important in allowing patients to make fully-informed consent with regard to treatment. Secondly, if a relationship between the presence of cognitive decline and the presence of biochemical markers of oxidative damage can be established, this can potentially lead to new treatment methods that may reduce the cognitive decline that has been associated with the chemotherapeutic process.

Tipo de estudio

De observación

Inscripción

30

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.

Ubicaciones de estudio

      • Singapore, Singapur
        • National University Hospital

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra de probabilidad

Población de estudio

A pilot study involving 30 women who have been diagnosed with breast cancer and will undergo standard adjuvant chemotherapy will be conducted first. This is to allow (1) the establishment of the acceptability of the procedure to patients and (2) documentation of the various effect sizes associated with (a) cognitive changes (b) changes in the level of the various biochemical markers following chemotherapy (c) the relationship between extent of cognitive decline and extent of DNA damage. It is estimated that up to approximately 100 patients can be recruited to participate in the main study.

Descripción

Inclusion Criteria:

  1. Histologically documented breast cancer
  2. Females greater than 18 years old
  3. Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2
  4. Requires to undergo standard-dose systemic adjuvant chemotherapy
  5. Patients must be informed of nature of study and sign an informed consent form

Exclusion criteria

a. Dementia/significantly altered mental status that will prohibit the understanding and/or giving of informed consent

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
1
Early breast cancer

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Chiung Ing Wong, MRCP, MB ChB, National University Hospital, Singapore

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

1 de noviembre de 2004

Fechas de registro del estudio

Enviado por primera vez

10 de julio de 2008

Primero enviado que cumplió con los criterios de control de calidad

10 de julio de 2008

Publicado por primera vez (Estimar)

11 de julio de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

31 de agosto de 2010

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

30 de agosto de 2010

Última verificación

1 de agosto de 2010

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • BR03/09/04

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 temprano

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