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Exercise During Active Surveillance for Prostate Cancer (ERASE)

8 aprile 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

52

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2H9
        • University of Alberta

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Exercise Group
Supervised high-intensity aerobic interval training (HIIT) during active surveillance
Comportamentale: High-intensity aerobic interval training (HIIT)
A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
Nessun intervento: Usual Care Group
The usual care group will be provided with standard active surveillance medical care.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes of Peak Oxygen Consumption (VO2peak)
Lasso di tempo: 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).
At baseline and 12-week (postintervention)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
Lasso di tempo: 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.
At baseline and 12-week (postintervention)
Changes of Immune-Related Phenotype
Lasso di tempo: 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.
At baseline and 12-week (postintervention)
Changes of Prostate-Specific Antigen (PSA)
Lasso di tempo: At baseline, 12-week (postintervention)
PSA will be assessed using blood samples.
At baseline, 12-week (postintervention)
Changes of Complete Blood Count with Differential (CBCD)
Lasso di tempo: At baseline and 12-week (postintervention)
CBCD, including RBC, WBC, HGB, HCT, PLT, LYMPH, BASO, EOS, MONO, NEUT, will be assessed using blood samples.
At baseline and 12-week (postintervention)
Changes of Insulin
Lasso di tempo: At baseline and 12-week (postintervention)
Fasting insulin levels will be assessed using blood samples.
At baseline and 12-week (postintervention)
Changes of Fasting Glucose
Lasso di tempo: At Baseline and 12-week postintervention
Fasting glucose levels will be assessed using blood samples.
At Baseline and 12-week postintervention
Changes of HbA1c
Lasso di tempo: At Baseline and 12-week postintervention
HbA1c will be assessed using using blood samples.
At Baseline and 12-week postintervention
Changes of Insulin-like Growth Factor (IGF)-axis
Lasso di tempo: At baseline and 12-week (postintervention)
IGF-axis, including circulating IGF-1 and IGF binding protein(IGFBP)-3, will be assessed using blood samples.
At baseline and 12-week (postintervention)
Changes of Pro-Inflammatory Cytokines
Lasso di tempo: 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.
At baseline and 12-week (postintervention)
Changes of High-Sensitivity C-Reactive Protein (hs-CRP)
Lasso di tempo: At Baseline and 12-week postintervention
hs-CRP will be assessed using blood samples.
At Baseline and 12-week postintervention
Changes of Adiponectin
Lasso di tempo: At Baseline and 12-week postintervention
Adiponectin will be assessed using blood samples.
At Baseline and 12-week postintervention
Physical Function
Lasso di tempo: 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).
At Baseline and 12-week postintervention
Health-Related Quality of Life
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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.
At baseline, 12-week (postintervention), 6-month, and 12-month
Prostate Cancer-Specific Quality of Life
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
Prostate cancer-specific quality of life will be assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Fear of Cancer Progression
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
Fear of cancer progression will be assessed using the Fear of Cancer Recurrence Inventory (FCRI) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Cancer Worry
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
Cancer worry will be assessed using the Cancer Worry Scale (CWS) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
General Anxiety
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
General anxiety will be assessed using the Anxiety (general): Spielberger State-Trait Anxiety Inventory (STAI) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Prostate Cancer-Specific Anxiety
Lasso di tempo: 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.
At baseline, 12-week (postintervention), 6-month, and 12-month
Depression
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Perceived Stress
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Self-esteem
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
Self-esteem will be assessed using the Rosenberg Self-Esteem Scale (RSES) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Fatigue
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
Fatigue will be assessed using the Functional Assessment of Cancer Therapy- Fatigue (FACT-F) questionnaire.
At baseline, 12-week (postintervention), 6-month, and 12-month
Physical Activity Level
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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).
At baseline, 12-week (postintervention), 6-month, and 12-month
Exercise Motivation
Lasso di tempo: At baseline, 12-week (postintervention), 6-month, and 12-month
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.
At baseline, 12-week (postintervention), 6-month, and 12-month
Body composition
Lasso di tempo: At baseline and 12-week (postintervention)
Body composition, including body weight and waist- and hip-circumferences, will be assessed using weight scales and a tape measure.
At baseline and 12-week (postintervention)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Alberta

Investigatori

  • Investigatore principale: Kerry S Courneya, PhD, University of Alberta

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2018

Completamento primario (Effettivo)

31 maggio 2020

Completamento dello studio (Effettivo)

31 maggio 2021

Date di iscrizione allo studio

Primo inviato

20 giugno 2017

Primo inviato che soddisfa i criteri di controllo qualità

28 giugno 2017

Primo Inserito (Effettivo)

29 giugno 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 aprile 2022

Ultimo verificato

1 novembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HREBA.CC-17-0248

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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