- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01596439
A Prospective Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive Function of Breast Cancer Patients
The primary objective of this prospective pilot study is to examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal therapy) and compare this to a group of healthy controls to evaluate if there is a difference. All randomized patients and their respective controls would be required to complete the computerized neuropsychological assessment CANTAB at certain time-points.These patients and controls would also be given on the same day as CANTAB testing, a set of questionnaires to evaluate subjective factors such as anxiety, depression, fatigue or menopausal symptoms which may also have an effect on cognition. Subjective assessment of cognitive function will rely on self-reporting by study participants using a validated questionnaire.The potential risks to subjects are minimal, as this is a study without any intervention regarding the medical management of patients. By participating in this study, subjects will be helping in the aim of determining if there is cognitive impairment post-therapy, and if so, how prevalent is this phenomenon, when it arises and how it changes with time. This will consequentially play an important role with regard to patient knowledge. Furthermore, if chemotherapy is shown to be associated with cognitive impairment, further studies can be carried out to determine the exact pathophysiology behind this phenomenon. This will allow for sensitive and timely detection of cognitive dysfunction in patients who have received chemotherapy and/or anti-hormonal therapy, and subsequently open the avenue for research in preventing or alleviating this phenomenon. This is crucial in improving patients' quality of life, social and occupational performance.
The investigators hypothesis is that systemic adjuvant therapy in the form of chemotherapy and/or anti-hormonal therapy given to primary breast cancer patients can cause cognitive impairment.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Singapore, Singapur
- Reclutamiento
- Nationa University Hospital
-
Contacto:
- Sing Huang Tan, MBBS
- Número de teléfono: +65 6779 5555
- Correo electrónico: Sing_Huang_Tan@nuhs.edu.sg
-
Investigador principal:
- Sing Huang Tan, MBBS
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Histologically confirmed stage I-III breast carcinoma
- < 65 years old
- Female
Exclusion Criteria:
- Previous exposure to chemotherapy/anti-hormonal therapy for any other malignancy
- Previous neoadjuvant therapy for breast cancer
- Concomitant second primary in-situ or invasive carcinoma or previous history of carcinoma/carcinoma-in-situ
- Known disease or injury to the central nervous system (including neurodegenerative diseases, epilepsy), severe visual or auditory disorders
- Motor weakness due to any cause which makes using a touchscreen computer difficult
- Known background of depression, anxiety disorders or other neurobehavioural conditions
- Ongoing use of tranquilisers or anti-depressants
- Previous neuropsychological testing
- Current or previous history of alcohol or drug dependent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
|---|---|
|
Examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy
|
To examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal therapy) and compare this to a group of healthy controls to evaluate if there is a difference.
|
Medidas de resultado secundarias
Medida de resultado |
|---|
|
Determine which cognitive domains in particular are affected
|
|
Assess certain other measures such as anxiety, depression, fatigue or menopausal symptoms which may have an impact on cognitive function using a set of validated questionnaires
|
|
Compare self-perceived cognitive deficits with objective measurements
|
|
Evaluate underlying biological pathways and susceptibility to cognitive dysfunction through blood biomarker studies, genetic polymorphisms and other mechanisms which we deem to be relevant
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Bhoo-Pathy N, Hartman M, Yip CH, Saxena N, Taib NA, Lim SE, Iau P, Adami HO, Bulgiba AM, Lee SC, Verkooijen HM. Ethnic differences in survival after breast cancer in South East Asia. PLoS One. 2012;7(2):e30995. doi: 10.1371/journal.pone.0030995. Epub 2012 Feb 21.
- Polychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998 Sep 19;352(9132):930-42.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Version 01
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .