Calendario›SNY›DOCETAXEL
DOCETAXEL
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)
Ensayo de Sanofi en Prostatic Neoplasms · Breast Cancer (del registro, en inglés).
Más ensayos de: Cáncer de mama.
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 84
- Centros
- 1
- Fin del objetivo primario
- mar 2011
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jun 2009.
Qué mide
Fatigue scores daily assessed using the 11-point (0-10) 0 is the lower score and 10 is the highest. this score is calculated using the MD Anderson Symptom Inventory (From baseline to the end of study (week 12)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective is: * To determine the efficacy of modafinil in the reduction of fatigue in patients with metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy The secondary objectives are: * To determine the effect of modafinil on quality of life (QoL) during docetaxel-based chemotherapy * To determine the effect of modafinil on patients physical activity level, functional status, number of chemotherapy cycles tolerated, sleep disturbance and depression, during docetaxel-based chemotherapy * To investigate the impact of tumour type, patient physical activity level, functional status, sleep disturbance and depression on the efficacy of modafinil at improving fatigue and quality of life during docetaxel-based chemotherapy. * To determine the safety and tolerability of modafinil during docetaxel-based chemotherapy
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00917748), actualizada en sep 2012.