Exercise During Active Surveillance for Prostate Cancer (ERASE)
A Phase II Randomized Controlled Trial of Exercise in Prostate Cancer Patients Undergoing Active Surveillance
Tutkimuksen yleiskatsaus
Tila
Tila
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Opintotyyppi
Opintotyyppi
Ilmoittautuminen (Todellinen)
Ilmoittautuminen
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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-
Alberta
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Edmonton, Alberta, Kanada, T6G2H9
- University of Alberta
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseiden lukumäärä
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
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Kokeellinen: Exercise Group
Supervised high-intensity aerobic interval training (HIIT) during active surveillance
|
A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
|
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Ei väliintuloa: Usual Care Group
The usual care group will be provided with standard active surveillance medical care.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Changes of Peak Oxygen Consumption (VO2peak)
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: At Baseline and 12-week postintervention
|
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
Aikaikkuna: At Baseline and 12-week postintervention
|
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
Aikaikkuna: 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)
|
|
Changes of Pro-Inflammatory Cytokines
Aikaikkuna: At baseline and 12-week (postintervention)
|
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)
Aikaikkuna: 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
Aikaikkuna: At Baseline and 12-week postintervention
|
Adiponectin will be assessed using blood samples.
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At Baseline and 12-week postintervention
|
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Physical Function
Aikaikkuna: At Baseline and 12-week postintervention
|
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
Aikaikkuna: 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
Aikaikkuna: 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
|
|
Fear of Cancer Progression
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
|
Prostate Cancer-Specific Anxiety
Aikaikkuna: At baseline, 12-week (postintervention), 6-month, and 12-month
|
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
|
|
Depression
Aikaikkuna: At baseline, 12-week (postintervention), 6-month, and 12-month
|
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
|
|
Perceived Stress
Aikaikkuna: At baseline, 12-week (postintervention), 6-month, and 12-month
|
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
Aikaikkuna: At baseline, 12-week (postintervention), 6-month, and 12-month
|
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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Kerry S Courneya, PhD, University of Alberta
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Ensisijainen valmistuminen
Opintojen valmistuminen (Todellinen)
Opintojen valmistuminen
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Ensimmäinen Lähetetty
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin päivitys julkaistu
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- HREBA.CC-17-0248
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Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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