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Exercise During and After Neoadjuvant Rectal Cancer Treatment (EXERT)

24 de mayo de 2022 actualizado por: University of Alberta

A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy

This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The EXERT trial is a single-center, prospective, two-armed, phase II randomized controlled trial designed to test the preliminary efficacy of exercise training in this clinical setting and to further evaluate its feasibility and safety. Participants will be 60 rectal cancer patients scheduled to receive long-course NACRT followed by total mesorectal excision. Participants will be randomly assigned to exercise training or usual care. Participants in the exercise training group will be asked to complete three supervised, high-intensity interval training sessions/week during NACRT and ≥ 150 min/week of unsupervised, moderate-to-vigorous-intensity, continuous exercise training after NACRT prior to surgery. Participants in the usual care group will be asked not to increase their exercise from baseline. Assessments will be completed pre NACRT, post NACRT, and pre surgery. The primary endpoint will be cardiorespiratory fitness (VO2 peak) at the post-NACRT time point assessed by a graded exercise test. Secondary endpoints will include functional fitness, quality of life, and symptom management. Exploratory clinical endpoints will include treatment toxicities, treatment completion, treatment response, and surgical complications.

Tipo de estudio

Intervencionista

Inscripción (Actual)

36

Fase

  • No aplica

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

  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 1Z2
        • Cross Cancer Institute

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

Todos

Descripción

Inclusion Criteria:

  • All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision

Exclusion Criteria:

  • Unable to consent
  • Unable to perform aerobic exercise
  • Intention to engage in a structured exercise program during NACRT and/or after NACRT and prior to surgery

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

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Ejercicio
Ejercicio aerobico
Conductual: Exercise
Supervised high-intensity interval training (HIIT) during NACRT followed by unsupervised moderate-to-vigorous intensity continuous exercise training after the completion of NACRT and before surgery
Sin intervención: Usual Care
Standard medical care

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Cardiorespiratory fitness
Periodo de tiempo: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
VO2 peak
pre-NACRT (baseline), post-NACRT (an average of 6 weeks)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cardiorespiratory fitness
Periodo de tiempo: pre-surgery (an average of 12 weeks)
VO2 peak
pre-surgery (an average of 12 weeks)
Functional fitness
Periodo de tiempo: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Senior's Fitness Test
pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Generic quality of life
Periodo de tiempo: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
European Organisation for Research and Treatment of Cancer core 30-item questionnaire
pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Disease specific quality of life
Periodo de tiempo: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer
pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Symptom burden
Periodo de tiempo: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
M.D. Anderson Symptom Inventory
pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Exercise motivation
Periodo de tiempo: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Theory of planned behaviour
pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Eligibility rate
Periodo de tiempo: up to 20 months
Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT
up to 20 months
Recruitment rate
Periodo de tiempo: up to 20 months
Number of patients randomized divided by the number of eligible patients
up to 20 months
Exercise adherence rate
Periodo de tiempo: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Exercise adherence during NACRT will be assessed by the number of exercise sessions attended out of 18 as well as adherence to the intensity and duration of the HIT intervals. Exercise adherence to the unsupervised exercise after NACRT will be assessed by self-report using the Godin Leisure-Time Exercise.
post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Follow-up assessment rate
Periodo de tiempo: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Number of patients in each group completing the objective outcomes (cardiorespiratory fitness and functional fitness) and patient-reported outcomes (quality of life, symptom burden) at each timepoint.
post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Safety: Adverse event rate
Periodo de tiempo: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
Number of serious adverse events that occur during exercise testing or the supervised exercise sessions
post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Treatment toxicities
Periodo de tiempo: every week during NACRT (up to 6 weeks)
CTCAE Version 3.0
every week during NACRT (up to 6 weeks)
Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date
Periodo de tiempo: post-NACRT (an average of 6 weeks)
Obtained from electronic medical records
post-NACRT (an average of 6 weeks)
Number of patients receiving ≥ 80% of their planned chemotherapy dose
Periodo de tiempo: post-NACRT (an average of 6 weeks)
Obtained from electronic medical records
post-NACRT (an average of 6 weeks)
Pathologic complete response rate
Periodo de tiempo: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Length of hospital stay
Periodo de tiempo: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Surgical approach
Periodo de tiempo: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Ostomy
Periodo de tiempo: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Sphincter preservation
Periodo de tiempo: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Blood loss
Periodo de tiempo: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)
Number of positive lymph nodes
Periodo de tiempo: post-surgery (an average of 12 weeks)
Obtained from electronic medical records
post-surgery (an average of 12 weeks)

Colaboradores e Investigadores

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

Patrocinador

University of Alberta

Colaboradores

Canadian Cancer Society (CCS)

Investigadores

  • Investigador principal: Kerry S Courneya, PhD, University of Alberta

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 (Actual)

26 de junio de 2017

Finalización primaria (Actual)

17 de octubre de 2019

Finalización del estudio (Actual)

1 de septiembre de 2020

Fechas de registro del estudio

Enviado por primera vez

9 de febrero de 2017

Primero enviado que cumplió con los criterios de control de calidad

10 de marzo de 2017

Publicado por primera vez (Actual)

17 de marzo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de mayo de 2022

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

24 de mayo de 2022

Última verificación

1 de marzo de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HREBA.CC-16-0986

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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