Exercise During Active Surveillance for Prostate Cancer (ERASE)
8 de abril de 2022 actualizado por: University of Alberta
A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance
The broad goal of the Exercise During Active Surveillance for Prostate Cancer (ERASE) trial is to examine the effects of exercise in prostate cancer patients undergoing active surveillance.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The ERASE Trial will be a phase II randomized controlled trial.
A total of 66 men with low- or intermediate-grade clinically localized prostate cancer undergoing active surveillance will be randomized to either a 12-week of supervised high-intensity aerobic interval training or usual care.
The primary outcome will be peak oxygen consumption (VO2peak) as a measure of physical fitness.
The secondary outcomes include tumour-related biomarkers, fear of cancer progression, quality of life, and psychological distress.
Exploratory outcomes will include indicators of cancer progression including prostate-specific antigen.
Based on this sample size, our study has 80% power with a two-tailed alpha <0.05 to detect a clinically meaningful effect of 3.5 ml/kg/min on our primary outcome of VO2max.
This power will also be sufficient for detecting differences in our secondary biomarkers and patient-reported outcomes if the effects are at least moderate (i.e., a standardized effect size of d=0.60).
Tipo de estudio
Intervencionista
Inscripción (Actual)
52
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
-
-
Alberta
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Edmonton, Alberta, Canadá, T6G2H9
- University of Alberta
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-
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
Masculino
Descripción
Inclusion Criteria:
- ≥18 years of age
- diagnosed with low or favorable intermediate grade localized PCa defined as PSA less than 10, Gleason Score 3+3 or 3+4 with low volume, and digital rectal examination (DRE) of T1C or T2A
- initiating or continuing active surveillance with no plans for treatment for prostate cancer in the next 6 months (e.g., radical prostatectomy, radiotherapy, or androgen deprivation therapy)
- screened for medical clearance for exercise testing and participation in vigorous aerobic exercise
- residing in a commutable area near Edmonton, Alberta
- willing to commute to the Behavioural Medicine Fitness Centre three times per week to attend a 12-week supervised high-intensity aerobic interval exercise program
Exclusion Criteria:
- having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise (e.g., known cardiac disease or uncontrolled hypertension)
- having contraindications for cardiopulmonary stress and/or physical fitness tests
- currently participating in a structured, vigorous exercise program.
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: Exercise Group
Supervised high-intensity aerobic interval training (HIIT) during active surveillance
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A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
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Sin intervención: Usual Care Group
The usual care group will be provided with standard active surveillance medical care.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes of Peak Oxygen Consumption (VO2peak)
Periodo de tiempo: At baseline and 12-week (postintervention)
|
VO2peak is a measure of cardiopulmonary fitness and a powerful surrogate outcome for cancer-specific and overall survival.
VO2peak will be defined as the highest oxygen-uptake value recorded during the test and quantified where participants reach a plateau in oxygen consumption, which will be expressed as relative to body mass (i.e., ml O2·kg-1·min-1).
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At baseline and 12-week (postintervention)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
Periodo de tiempo: At baseline and 12-week (postintervention)
|
NKCA significantly contributes to the regulation of tumour suppression in response to exercise and it has been demonstrated to have a diagnostic value in patients with cancer.
NK cell activities are assessed using blood analysis as the total number of circulating NK cells and their cytotoxic activity.
NK cell counts and NKCA will be measured using the phenotypic markers of NK cells (CD3-CD16+CD56+).
NKCA will be expressed as the percentage of target cells killed by a sample of 100,000 peripheral blood mononuclear cells at the effector-to-target ratios of 5:1, 20:1, 40:1, and 100:1.
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At baseline and 12-week (postintervention)
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Changes of Immune-Related Phenotype
Periodo de tiempo: At baseline and 12-week (postintervention)
|
Immune-related phenotypic markers, including CD3, CD16, CD56, and CD107 (on the frozen) and CD4, CD8, CD20, CD25, CD11, CD45RA, CD45RO, CD16, CD56, CD107 activation (fresh on whole blood), will be assessed using blood samples.
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At baseline and 12-week (postintervention)
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Changes of Prostate-Specific Antigen (PSA)
Periodo de tiempo: At baseline, 12-week (postintervention)
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PSA will be assessed using blood samples.
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At baseline, 12-week (postintervention)
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Changes of Complete Blood Count with Differential (CBCD)
Periodo de tiempo: At baseline and 12-week (postintervention)
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CBCD, including RBC, WBC, HGB, HCT, PLT, LYMPH, BASO, EOS, MONO, NEUT, will be assessed using blood samples.
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At baseline and 12-week (postintervention)
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Changes of Insulin
Periodo de tiempo: At baseline and 12-week (postintervention)
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Fasting insulin levels will be assessed using blood samples.
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At baseline and 12-week (postintervention)
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Changes of Fasting Glucose
Periodo de tiempo: At Baseline and 12-week postintervention
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Fasting glucose levels will be assessed using blood samples.
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At Baseline and 12-week postintervention
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Changes of HbA1c
Periodo de tiempo: At Baseline and 12-week postintervention
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HbA1c will be assessed using using blood samples.
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At Baseline and 12-week postintervention
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Changes of Insulin-like Growth Factor (IGF)-axis
Periodo de tiempo: At baseline and 12-week (postintervention)
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IGF-axis, including circulating IGF-1 and IGF binding protein(IGFBP)-3, will be assessed using blood samples.
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At baseline and 12-week (postintervention)
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Changes of Pro-Inflammatory Cytokines
Periodo de tiempo: At baseline and 12-week (postintervention)
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Pro-inflammatory cytokines, including IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, and TNF-α, will be assessed.
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At baseline and 12-week (postintervention)
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Changes of High-Sensitivity C-Reactive Protein (hs-CRP)
Periodo de tiempo: At Baseline and 12-week postintervention
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hs-CRP will be assessed using blood samples.
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At Baseline and 12-week postintervention
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Changes of Adiponectin
Periodo de tiempo: At Baseline and 12-week postintervention
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Adiponectin will be assessed using blood samples.
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At Baseline and 12-week postintervention
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Physical Function
Periodo de tiempo: At Baseline and 12-week postintervention
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Physical function, consisting of strength, flexibility, and agility components, will be assessed by the Senior's Fitness Test (SFT).
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At Baseline and 12-week postintervention
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Health-Related Quality of Life
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Health-related quality of life will be assessed using the European Organization for Research and Treatment of Cancer- Quality of Life Questionnaire (EORTC-QLQ) - C30 questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Prostate Cancer-Specific Quality of Life
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Prostate cancer-specific quality of life will be assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Fear of Cancer Progression
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Fear of cancer progression will be assessed using the Fear of Cancer Recurrence Inventory (FCRI) questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Cancer Worry
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Cancer worry will be assessed using the Cancer Worry Scale (CWS) questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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General Anxiety
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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General anxiety will be assessed using the Anxiety (general): Spielberger State-Trait Anxiety Inventory (STAI) questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Prostate Cancer-Specific Anxiety
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Prostate cancer-specific anxiety will be assessed using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Depression
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Perceived Stress
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Self-esteem
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES) questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Fatigue
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Fatigue will be assessed using the Functional Assessment of Cancer Therapy- Fatigue (FACT-F) questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Physical Activity Level
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Physical activity level, consisting of light-, moderate-, and vigorous aerobic exercise and resistance exercise, will be assessed using the Godin Leisure-Time Exercise Questionnaire (GLTEQ).
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Exercise Motivation
Periodo de tiempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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Exercise motivation, consisting of Theory of Planned Behaviour (TPB) constructs (instrumental and affective attitudes, subjective norms, intention and perceived behavioral control), will be assessed using questionnaire.
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At baseline, 12-week (postintervention), 6-month, and 12-month
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Body composition
Periodo de tiempo: At baseline and 12-week (postintervention)
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Body composition, including body weight and waist- and hip-circumferences, will be assessed using weight scales and a tape measure.
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At baseline and 12-week (postintervention)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
- Kang DW, Fairey AS, Boule NG, Field CJ, Wharton SA, Courneya KS. Effects of Exercise on Cardiorespiratory Fitness and Biochemical Progression in Men With Localized Prostate Cancer Under Active Surveillance: The ERASE Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1487-1495. doi: 10.1001/jamaoncol.2021.3067.
- Kang DW, Fairey AS, Boule NG, Field CJ, Wharton SA, Courneya KS. A Randomized Trial of the Effects of Exercise on Anxiety, Fear of Cancer Progression and Quality of Life in Prostate Cancer Patients on Active Surveillance. J Urol. 2022 Apr;207(4):814-822. doi: 10.1097/JU.0000000000002334. Epub 2022 Feb 17.
- Kang DW, Boule NG, Field CJ, Fairey AS, Courneya KS. Effects of supervised high-intensity interval training on motivational outcomes in men with prostate cancer undergoing active surveillance: results from a randomized controlled trial. Int J Behav Nutr Phys Act. 2022 Sep 29;19(1):126. doi: 10.1186/s12966-022-01365-2.
- Kang DW, Fairey AS, Boule NG, Field CJ, Courneya KS. Exercise duRing Active Surveillance for prostatE cancer-the ERASE trial: a study protocol of a phase II randomised controlled trial. BMJ Open. 2019 Jul 4;9(7):e026438. doi: 10.1136/bmjopen-2018-026438.
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)
1 de julio de 2018
Finalización primaria (Actual)
31 de mayo de 2020
Finalización del estudio (Actual)
31 de mayo de 2021
Fechas de registro del estudio
Enviado por primera vez
20 de junio de 2017
Primero enviado que cumplió con los criterios de control de calidad
28 de junio de 2017
Publicado por primera vez (Actual)
29 de junio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de abril de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
8 de abril de 2022
Última verificación
1 de noviembre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HREBA.CC-17-0248
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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