Descripción del proyecto
Una tecnología de ultrasonido para el tratamiento paliativo del dolor óseo metastásico
Las metástasis óseas que cursan con un dolor espantoso son comunes en los estadios avanzados de las neoplasias malignas, y el dolor óseo metastásico es difícil de tratar. La radioterapia (RT) es el tratamiento paliativo estándar para el dolor óseo metastásico, pero a menudo produce un alivio inadecuado del dolor. La técnica de ultrasonidos focalizados de alta intensidad guiados por resonancia magnética (MR-HIFU, por sus siglas en inglés) utiliza la imagen por resonancia magnética para guiar un haz de ultrasonidos que calienta y destruye el tejido en la lesión. Estudios preliminares sugieren que la técnica de MR-HIFU induce un alivio rápido del dolor. El objetivo del proyecto financiado con fondos europeos FURTHER es corroborar la efectividad de la técnica de MR-HIFU como una alternativa u opción terapéutica adicional para aliviar el dolor óseo metastásico. El proyecto llevará a cabo un ensayo controlado aleatorizado que compare la respuesta al dolor en pacientes tratados solo con RT, solo con MR-HIFU y con RT combinada con MR-HIFU. Es más, se investigará la adopción generalizada de la técnica de MR-HIFU y cómo mejorar el acceso a este tratamiento.
Objetivo
"Bone metastases are a common manifestation of advanced cancer, with pain as a devastating consequence. Due to rising cancer incidence rates and improving survival, the number of cancer patients living long enough to develop bone metastases is increasing rapidly. Metastatic bone pain is difficult to manage and has a detrimental impact on quality of life of patients, their partners and care-givers.
Radiation therapy (RT), the standard treatment for palliation of metastatic bone pain, is easy to administer and well tolerated. However, RT is only effective in 60-70% of patients and usually takes four weeks before inducing pain response. Inadequate pain relief is therefore common and alternative treatment options are urgently needed.
Pain palliation may be substantially improved by including MR-HIFU as alternative or in addition to RT. Preliminary studies suggest that MR-HIFU induces rapid pain relief (within days), and may palliate pain in patients in whom RT is not effective. Currently, strong evidence and context is lacking for wide-spread implementation of MR-HIFU into routine care.
The FURTHER project aims to demonstrate (cost)effectiveness of MR-HIFU as an alternative or additional treatment option to relief metastatic bone pain. For this purpose, a three arm international randomized controlled trial (RCT) including 216 patients will be conducted comparing early and late pain response in patients treated with RT only, MR-HIFU only, and RT with MR-HIFU. A prediction model will be developed to identify patients who are likely to benefit from MR-HIFU in order to allow (cost-) effective use of the treatment. In addition, a registry will be set up in which we will run the pain education study Educate-FURTHER, henceforth ""the Pain Education study"", to evaluate the effectiveness of adding pain education to the pain management strategy. Finally, FURTHER will map and analyse socio-economic barriers for integration of MR-HIFU in routine care in the wider European context and make recommendations on how to provide equal access to this promising new treatment."
Ámbito científico
Palabras clave
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SC1-2018-Single-Stage-RTD
Régimen de financiación
RIA - Research and Innovation actionCoordinador
3584 CX Utrecht
Países Bajos