Exercise During Active Surveillance for Prostate Cancer (ERASE)
8 avril 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Réel)
52
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alberta
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Edmonton, Alberta, Canada, T6G2H9
- University of Alberta
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Aucune intervention: Usual Care Group
The usual care group will be provided with standard active surveillance medical care.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes of Peak Oxygen Consumption (VO2peak)
Délai: At baseline and 12-week (postintervention)
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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)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
Délai: At baseline and 12-week (postintervention)
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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
Délai: At baseline and 12-week (postintervention)
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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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kerry S Courneya, PhD, University of Alberta
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2018
Achèvement primaire (Réel)
31 mai 2020
Achèvement de l'étude (Réel)
31 mai 2021
Dates d'inscription aux études
Première soumission
20 juin 2017
Première soumission répondant aux critères de contrôle qualité
28 juin 2017
Première publication (Réel)
29 juin 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 avril 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 avril 2022
Dernière vérification
1 novembre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HREBA.CC-17-0248
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
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Essais cliniques sur High-intensity aerobic interval training (HIIT)
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University of Alabama at BirminghamEunice Kennedy Shriver National Institute of Child Health and Human Development...Complété