- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00653718
Musculoskeletal Pain in Postmenopausal, Early Breast Cancer Patients Receiving Aromatase Inhibitor Therapy - A Pilot Study (AIMS)
In 2005, the EBCIG demonstrated the efficacy of tamoxifen in improving overall survival in hormone receptor positive breast cancers. However, tamoxifen shows partial estrogen agonist activity, which is responsible for the drug's detrimental effects such as endometrial carcinoma, thromboembolism, and tamoxifen resistance. More recently, aromatase inhibitors have been shown to be superior to tamoxifen in the metastatic and adjuvant settings. The ATAC trial demonstrated improved disease-free survival (DFS) for 5 years of anastrozole compared to 5 years of tamoxifen 3. The BIG 1-98 trial results demonstrated that after a median follow-up of 25.8 months, letrozole improved DFS and distant DFS when compared to tamoxifen. Based on these results, adjuvant hormonal therapy with Aromatase Inhibitors (AI) has become the preferred therapy for post-menopausal woman.
However, AI therapy is also associated with toxicities that merit in-depth studies, one of them being an increase in musculoskeletal pain. In the ATAC trial, at a median follow-up of 5.7 years, arthralgia was significantly higher (35.6% vs. 29.4%) and fractures were also increased (11.0% vs. 7.7%) when anastrozole was administered for 5 years following surgery with or without chemotherapy 3. The incidence of arthralgia was also significantly higher in the MA-17 trial, with 25% of patients receiving letrozole developing arthralgia compared with 21% in the placebo group following 5 to 6 years of tamoxifen 5.
Traditionally in cancer clinical trials, the reporting of musculoskeletal pain has been based on the "Common Terminology Criteria for Adverse Events", which covers a wide range of symptoms and does not facilitate the documentation of a pain syndrome in a specific manner. Therefore, there is a need to design a study that will describe the nature of the pain associated with the administration of AI therapy using tools that have been validated for capturing a multidimensional phenomenon such as pain.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Quebec
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Montréal, Quebec, Canadá, H2W 1T8
- Centre Hospitalier de l'Université de Montréal
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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:
- Female
- Invasive carcinoma of the breast confirmed by needle biopsy or final pathological evaluation of the surgical specimen
- Breast cancer Stage I, II or IIIa
- ER and/or PR+
- No evidence of metastatic disease
- Post-menopausal
- May or may not have received adjuvant or neoadjuvant chemotherapy
- Bilateral infiltrating carcinoma are eligible
Exclusion Criteria:
- Men not eligible
- Other malignancies
- Patients who have received neoadjuvant or adjuvant endocrine therapy with tamoxifen or an aromatase inhibitor
- Ongoing treatment with any sex hormonal therapy (these patients are eligible if this therapy is discontinued prior to entry)
- Therapy with hormonal agent such as raloxifene for osteoporosis
- Patients receiving glucocorticoids
- Psychiatric or addictive disorders
- Inability to read English or French
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Musculoskeletal pain
Periodo de tiempo: Every two weeks
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Every two weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Lymphocyte gene expression profiling
Periodo de tiempo: Every two weeks
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Every two weeks
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: André Robidoux, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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 (Actual)
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
- D5390L00068
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. .
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