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Lifestyles Of Health And Sustainability for Breast Cancer Survivors

2021年4月6日 更新者：In Deok Kong, MD、Wonju Severance Christian Hospital

Lifestyle Intervention for Breast Cancer Survivors

The purpose of this study is to examine the effects of exercise program on health-related physical fitness and biomarkers among breast cancer survivors.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Patients and survivors of breast cancer present impaired physical fitness and various complications including acute and chronic pain, severe fatigue, limited range of motion, and bone loss attributable to anticancer treatments. Therefore, regular exercise during and following cancer treatments has been recommended to enhance physical capabilities and relieve side-effect severities, leading to an improved quality of life. Despite the known general benefits to patients with cancer, the effects of exercise on cancer-related biomarkers and their modulators remain unclear.

PRIMARY OBJECTIVES:

I. To determine whether a 12-week exercise intervention will improve components of health-related physical fitness by measuring cardiorespiratory fitness, muscular exercise capacity and flexibility in breast cancer survivors.

II. To determine whether a 12-week exercise intervention will improve risk parameters of metabolic disease by measuring changes in body composition, waist circumference, blood pressure, and circulating levels of glucose, insulin, lipids components and C-reactive protein in breast cancer survivors.

III. To determine whether a 12-week exercise intervention will conduce to changes of cancer-related biomarker by measuring in serum levels of dickkopf-related protein 1 (DKK1), secreted frizzled-related protein 1 (SFRP1), sclerostin, osteoprotegerin, osteopontin, growth differentiation factor 15 (GDF-15), insulin like growth factor 1 (IGF-1), and IGFBP-3 in breast cancer survivors.

IV. To determine whether a 12-week exercise intervention will result in a improvement in inflammatory cytokines and adipokines by measuring in serum levels of interleukin 1 beta (IL-1β), IL-10, IL-11, tumor necrosis factor alpha (TNFα), leptin and adiponectin in breast cancer survivors.

V. To determine whether a 12-week exercise intervention will conduce to changes of myokines by measuring in serum levels of brain-derived neurotrophic factor (BDNF), IL-8, IL-15, fatty acid-binding protein 3 (FABP3), leukemia inhibitory factor (LIF), follistatin, fractalkine, fibroblast growth factor 21 (FGF-21), osteonectin and irisin in breast cancer survivors.

研究の種類

介入

入学 (予想される)

60

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。

研究連絡先

研究場所

  • 大韓民国
    • Gangwon-do
      • Wonju、Gangwon-do、大韓民国
        • 募集
        • Center for Exercise medicine; Yonsei University
        • コンタクト：
        • 主任研究者：
          • Jae Seung Chang, Ph.D

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～64年 (大人)

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

女性

説明

Inclusion Criteria:

  • Have diagnosed as a stage of I-III breast cancer
  • Have undergone a lumpectomy or mastectomy
  • Have completed neoadjuvant/adjuvant chemotherapy and able to initiate Exercise program
  • Nonsmokers (i.e., not smoking during previous 12 months)
  • Able to provide physician clearance to participate in exercise program for 12 weeks

Exclusion Criteria:

  • History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
  • Weight reduction >= 10% within past 6 months
  • Metastatic disease
  • Participate in more than 60 minutes of exercise per week in the past 6 months
  • Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity

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：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Exercise in breast cancer survivors
Combined aerobic and strength exercise training for 12 weeks under supervision
行動：Combined aerobic and strength exercise training
Subjects participate in supervised exercise sessions for 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30 minutes once weekly for 12 weeks.
介入なし：No exercise in breast cancer survivors
Lifestyle counseling and standard of care follow up for 12 weeks
偽コンパレータ：Exercise in healthy subjects
Age-matched healthy subjects. Combined aerobic and strength exercise training for 12 weeks under supervision
行動：Combined aerobic and strength exercise training
Subjects participate in supervised exercise sessions for 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30 minutes once weekly for 12 weeks.

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
Changes of health-related physical fitness components (1).
時間枠：Changes from baseline aerobic capacity at 12 weeks
Aerobic capacity is assessed using multi-stage 20 meters shuttle run test (the maximum number of repetitions).
Changes from baseline aerobic capacity at 12 weeks
Changes of health-related physical fitness components (2).
時間枠：Changes from baseline muscular endurance at 12 weeks
Muscular endurance is assessed using sit-up test for 30 seconds (the maximum number of repetitions).
Changes from baseline muscular endurance at 12 weeks
Changes of health-related physical fitness components (3).
時間枠：Changes from baseline muscular strength at 12 weeks
Muscular strength is assessed by the maximum voluntary strength of handgrip (kg).
Changes from baseline muscular strength at 12 weeks
Changes of health-related physical fitness components (4).
時間枠：Changes from baseline muscular power at 12 weeks
Muscular power is assessed using standing long jump test (the maximum horizontal distance of two trials, cm).
Changes from baseline muscular power at 12 weeks
Changes of health-related physical fitness components (5).
時間枠：Changes from baseline agility at 12 weeks
Agility is assessed using 10 meters agility shuttle run test (the time taken to complete a 10 meters course is recorded, seconds).
Changes from baseline agility at 12 weeks
Changes of health-related physical fitness components (6).
時間枠：Changes from baseline flexibility at 12 weeks
Flexibility is assessed using sit and reach test (the greater distance of two trials, cm)
Changes from baseline flexibility at 12 weeks
Changes of anthropometric parameters (1).
時間枠：Changes from baseline waist circumference at 12 weeks
Waist circumference is measured at the midpoint between the lower rib margin and the iliac crest (expressed in cm).
Changes from baseline waist circumference at 12 weeks
Changes of anthropometric parameters (2).
時間枠：Changes from baseline BMI at 12 weeks
BMI calculated as body weight / height (kg per square meters).
Changes from baseline BMI at 12 weeks
Changes of body composition parameters (1).
時間枠：Changes from baseline body fat mass at 12 weeks
Body fat mass is measured by a bio-impedance analyzer (expressed as kg).
Changes from baseline body fat mass at 12 weeks
Changes of body composition parameters (2).
時間枠：Changes from baseline lean body mass at 12 weeks
Lean body mass is measured by a bio-impedance analyzer (expressed as kg).
Changes from baseline lean body mass at 12 weeks
Changes of body composition parameters (3).
時間枠：Changes from baseline percentage body fat at 12 weeks
Percentage body fat is calculated as body fat mass (kg) divided by weight (kg).
Changes from baseline percentage body fat at 12 weeks
Changes of serum levels of Wnt signaling-related molecules (1).
時間枠：Changes from baseline serum levels of DKK1 at 12 weeks
The serum concentration of DKK1 is measured by commercial enzyme-linked immunosorbent assay kits (Minimal detectable density, 15.6 pg/ml; Standard curve range, 31.2 - 2,000 pg/ml, R&D systems).
Changes from baseline serum levels of DKK1 at 12 weeks
Changes of serum levels of Wnt signaling-related molecules (2).
時間枠：Changes from baseline serum levels of Sclerostin at 12 weeks
The serum concentration of sclerostin is measured by commercial enzyme-linked immunosorbent assay kits (Minimal detectable density, 6.96 pg/ml; Standard curve range, 7.49 - 1,820 pg/ml, R&D systems).
Changes from baseline serum levels of Sclerostin at 12 weeks
Changes of serum levels of Wnt signaling-related molecules (3).
時間枠：Changes from baseline serum levels of SFRP1 at 12 weeks
The serum concentration of SFRP1 is measured by commercial enzyme-linked immunosorbent assay kits (Minimal detectable density, 53 pg/ml; Standard curve range, 156 - 10,000 pg/ml, USCN Life Science Inc.).
Changes from baseline serum levels of SFRP1 at 12 weeks
Changes of serum levels of Wnt signaling-related molecules (4).
時間枠：Changes from baseline serum levels of β-catenin at 12 weeks
The serum concentration of β-catenin is measured by commercial enzyme-linked immunosorbent assay kits (Minimal detectable density, 3.9 pg/ml; Standard curve range, 15.6 - 1000 pg/ml, Cusabio Biotech).
Changes from baseline serum levels of β-catenin at 12 weeks
Changes of serum levels of Wnt signaling-related molecules (5).
時間枠：Changes from baseline serum levels of WISP-1 at 12 weeks
The serum concentration of WISP-1 is measured by commercial chemiluminescent immunoassay kits (Minimal detectable density, 0.97 pg/ml; Standard curve range, 2.74 - 2,000 pg/ml, USCN Life Science Inc.).
Changes from baseline serum levels of WISP-1 at 12 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Changes of serum levels of cancer-related molecules (1).
時間枠：Changes from baseline serum levels of osteoprotegerin at 12 weeks
The serum concentration of osteoprotegerin is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 3.62 pg/ml; Standard curve range, 81.4 - 19,770 pg/ml, R&D systems).
Changes from baseline serum levels of osteoprotegerin at 12 weeks
Changes of serum levels of cancer-related molecules (2).
時間枠：Changes from baseline serum levels of osteopontin at 12 weeks
The serum concentration of osteopontin is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 413 pg/ml; Standard curve range, 3.4 - 826.9 ng/ml, R&D systems).
Changes from baseline serum levels of osteopontin at 12 weeks
Changes of serum levels of cancer-related molecules (3).
時間枠：Changes from baseline serum levels of GDF-15 at 12 weeks
The serum concentration of GDF-15 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 1.2 pg/ml; Standard curve range, 34 - 8,270 pg/ml, R&D systems).
Changes from baseline serum levels of GDF-15 at 12 weeks
Changes of serum levels of adipokines (1).
時間枠：Changes from baseline serum levels of adiponectin at 12 weeks
The serum concentration of adiponectin is measured by commercial enzyme-linked immunosorbent assay kits (Minimal detectable density, 0.891 ng/ml; Standard curve range, 3.9 - 250 ng/ml, R&D systems).
Changes from baseline serum levels of adiponectin at 12 weeks
Changes of serum levels of adipokines (2).
時間枠：Changes from baseline serum levels of leptin at 12 weeks
The serum concentration of leptin is measured by commercial enzyme-linked immunosorbent assay kits (Minimal detectable density, 7.8 pg/ml; Standard curve range, 15.6 - 1,000 ng/ml, R&D systems).
Changes from baseline serum levels of leptin at 12 weeks
Changes of serum levels of myokines (1).
時間枠：Changes from baseline serum levels of BDNF at 12 weeks
The serum concentration of BDNF is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 0.32 pg/ml; Standard curve range, 10.9 - 2,650 pg/ml, R&D systems).
Changes from baseline serum levels of BDNF at 12 weeks
Changes of serum levels of myokines (2).
時間枠：Changes from baseline serum levels of IL-8 at 12 weeks
The serum concentration of IL-8 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 1.8 pg/ml; Standard curve range, 8.19 - 1,990 pg/ml, R&D systems).
Changes from baseline serum levels of IL-8 at 12 weeks
Changes of serum levels of myokines (3).
時間枠：Changes from baseline serum levels of IL-15 at 12 weeks
The serum concentration of IL-15 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 1.01 pg/ml; Standard curve range, 7.7 - 18,700 pg/ml, R&D systems).
Changes from baseline serum levels of IL-15 at 12 weeks
Changes of serum levels of myokines (4).
時間枠：Changes from baseline serum levels of FABP3 at 12 weeks
The serum concentration of FABP3 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 472 pg/ml; Standard curve range, 1.3 - 312.2 ng/ml, R&D systems).
Changes from baseline serum levels of FABP3 at 12 weeks
Changes of serum levels of myokines (5).
時間枠：Changes from baseline serum levels of LIF at 12 weeks
The serum concentration of LIF is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 9.31 pg/ml; Standard curve range, 68.1 - 16,550 pg/ml, R&D systems).
Changes from baseline serum levels of LIF at 12 weeks
Changes of serum levels of myokines (6).
時間枠：Changes from baseline serum levels of follistatin at 12 weeks
The serum concentration of follistatin is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 133 pg/ml; Standard curve range, 2.6 - 650 ng/ml, R&D systems).
Changes from baseline serum levels of follistatin at 12 weeks
Changes of serum levels of myokines (7).
時間枠：Changes from baseline serum levels of fractalkine at 12 weeks
The serum concentration of fractalkine is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 64.8 pg/ml; Standard curve range, 1.3 - 325.8 ng/ml, R&D systems).
Changes from baseline serum levels of fractalkine at 12 weeks
Changes of serum levels of myokines (8).
時間枠：Changes from baseline serum levels of FGF-21 at 12 weeks
The serum concentration of FGF-21 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 27 pg/ml; Standard curve range, 623 - 151,330 pg/ml, R&D systems).
Changes from baseline serum levels of FGF-21 at 12 weeks
Changes of serum levels of myokines (9).
時間枠：Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks
The serum concentration of SPARC (osteonectin) is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 97.9 pg/ml; Standard curve range, 3.4 - 829.9 ng/ml, R&D systems).
Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks
Changes of serum levels of myokines (10).
時間枠：Changes from baseline serum levels of irisin at 12 weeks
The serum concentration of irisin is measured by commercial enzyme-linked immunosorbent assay kits (Minimal detectable density, 1.29 ng/ml; Standard curve range, 0.1 - 1,000 ng/ml, Phoenix Pharmaceuticals).
Changes from baseline serum levels of irisin at 12 weeks
Changes of serum levels of inflammatory-related cytokines (1)
時間枠：Changes from baseline serum levels of IL-1 beta at 12 weeks
The serum concentration of IL-1 beta is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 0.8 pg/ml; Standard curve range, 17.8 - 4,320 pg/ml, R&D systems).
Changes from baseline serum levels of IL-1 beta at 12 weeks
Changes of serum levels of inflammatory-related cytokines (2)
時間枠：Changes from baseline serum levels of IL-10 at 12 weeks
The serum concentration of IL-10 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 1.6 pg/ml; Standard curve range, 13.7 - 3,340 pg/ml, R&D systems).
Changes from baseline serum levels of IL-10 at 12 weeks
Changes of serum levels of inflammatory-related cytokines (3)
時間枠：Changes from baseline serum levels of IL-11 at 12 weeks
The serum concentration of IL-11 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 24.7 pg/ml; Standard curve range, 0.5 - 125.4 ng/ml, R&D systems).
Changes from baseline serum levels of IL-11 at 12 weeks
Changes of serum levels of inflammatory-related cytokines (4)
時間枠：Changes from baseline serum levels of TNF-alpha at 12 weeks
The serum concentration of TNF-alpha is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 1.2 pg/ml; Standard curve range, 14 - 3,410 pg/ml, R&D systems).
Changes from baseline serum levels of TNF-alpha at 12 weeks
Changes of bone mineral density
時間枠：Changes from baseline bone mineral density at 12 weeks
Bone mineral density is expressed as T-score, which is measured by a compact ultrasonometer at calcaneus (Achilles Express, GE LUNAR Corp., Madison, WI)
Changes from baseline bone mineral density at 12 weeks

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

Wonju Severance Christian Hospital

捜査官

  • スタディチェア：In Deok Kong, Professor、Yonsei University

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

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

2014年5月1日

一次修了 (予想される)

2023年3月1日

研究の完了 (予想される)

2023年12月1日

試験登録日

最初に提出

2016年8月21日

QC基準を満たした最初の提出物

2016年9月4日

最初の投稿 (見積もり)

2016年9月9日

学習記録の更新

投稿された最後の更新 (実際)

2021年4月8日

QC基準を満たした最後の更新が送信されました

2021年4月6日

最終確認日

2021年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • LOHAS-BCS

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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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