Exercise During Active Surveillance for Prostate Cancer (ERASE)
2022年4月8日 更新者：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.
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (実際)
52
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Alberta
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Edmonton、Alberta、カナダ、T6G2H9
- University of Alberta
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：Usual Care Group
The usual care group will be provided with standard active surveillance medical care.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes of Peak Oxygen Consumption (VO2peak)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes of Natural Killer Cell Cytotoxic Activity (NKCA) and Counts
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Kerry S Courneya, PhD、University of Alberta
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年7月1日
一次修了 (実際)
2020年5月31日
研究の完了 (実際)
2021年5月31日
試験登録日
最初に提出
2017年6月20日
QC基準を満たした最初の提出物
2017年6月28日
最初の投稿 (実際)
2017年6月29日
学習記録の更新
投稿された最後の更新 (実際)
2022年4月18日
QC基準を満たした最後の更新が送信されました
2022年4月8日
最終確認日
2021年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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