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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jae Seung Chang, Ph.D
- 电话号码：+82-33-741-0296
- 邮箱：godbless@yonsei.ac.kr
学习地点
-
-
Gangwon-do
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Wonju、Gangwon-do、大韩民国
- 招聘中
- Center for Exercise medicine; Yonsei University
-
接触：
- Jae Seung Chang, Ph.D
- 电话号码：+82-70-8826-0292
- 邮箱：godbless@yonsei.ac.kr
-
首席研究员：
- Jae Seung Chang, Ph.D
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 64年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Exercise in breast cancer survivors
Combined aerobic and strength exercise training for 12 weeks under supervision
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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.
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无干预：No exercise in breast cancer survivors
Lifestyle counseling and standard of care follow up for 12 weeks
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假比较器：Exercise in healthy subjects
Age-matched healthy subjects.
Combined aerobic and strength exercise training for 12 weeks under supervision
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes of health-related physical fitness components (1).
大体时间：Changes from baseline aerobic capacity at 12 weeks
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Aerobic capacity is assessed using multi-stage 20 meters shuttle run test (the maximum number of repetitions).
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Changes from baseline aerobic capacity at 12 weeks
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Changes of health-related physical fitness components (2).
大体时间：Changes from baseline muscular endurance at 12 weeks
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Muscular endurance is assessed using sit-up test for 30 seconds (the maximum number of repetitions).
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Changes from baseline muscular endurance at 12 weeks
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Changes of health-related physical fitness components (3).
大体时间：Changes from baseline muscular strength at 12 weeks
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Muscular strength is assessed by the maximum voluntary strength of handgrip (kg).
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Changes from baseline muscular strength at 12 weeks
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Changes of health-related physical fitness components (4).
大体时间：Changes from baseline muscular power at 12 weeks
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Muscular power is assessed using standing long jump test (the maximum horizontal distance of two trials, cm).
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Changes from baseline muscular power at 12 weeks
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Changes of health-related physical fitness components (5).
大体时间：Changes from baseline agility at 12 weeks
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Agility is assessed using 10 meters agility shuttle run test (the time taken to complete a 10 meters course is recorded, seconds).
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Changes from baseline agility at 12 weeks
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Changes of health-related physical fitness components (6).
大体时间：Changes from baseline flexibility at 12 weeks
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Flexibility is assessed using sit and reach test (the greater distance of two trials, cm)
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Changes from baseline flexibility at 12 weeks
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Changes of anthropometric parameters (1).
大体时间：Changes from baseline waist circumference at 12 weeks
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Waist circumference is measured at the midpoint between the lower rib margin and the iliac crest (expressed in cm).
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Changes from baseline waist circumference at 12 weeks
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Changes of anthropometric parameters (2).
大体时间：Changes from baseline BMI at 12 weeks
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BMI calculated as body weight / height (kg per square meters).
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Changes from baseline BMI at 12 weeks
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Changes of body composition parameters (1).
大体时间：Changes from baseline body fat mass at 12 weeks
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Body fat mass is measured by a bio-impedance analyzer (expressed as kg).
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Changes from baseline body fat mass at 12 weeks
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Changes of body composition parameters (2).
大体时间：Changes from baseline lean body mass at 12 weeks
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Lean body mass is measured by a bio-impedance analyzer (expressed as kg).
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Changes from baseline lean body mass at 12 weeks
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Changes of body composition parameters (3).
大体时间：Changes from baseline percentage body fat at 12 weeks
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Percentage body fat is calculated as body fat mass (kg) divided by weight (kg).
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Changes from baseline percentage body fat at 12 weeks
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Changes of serum levels of Wnt signaling-related molecules (1).
大体时间：Changes from baseline serum levels of DKK1 at 12 weeks
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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).
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Changes from baseline serum levels of DKK1 at 12 weeks
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Changes of serum levels of Wnt signaling-related molecules (2).
大体时间：Changes from baseline serum levels of Sclerostin at 12 weeks
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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).
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Changes from baseline serum levels of Sclerostin at 12 weeks
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Changes of serum levels of Wnt signaling-related molecules (3).
大体时间：Changes from baseline serum levels of SFRP1 at 12 weeks
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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.).
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Changes from baseline serum levels of SFRP1 at 12 weeks
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Changes of serum levels of Wnt signaling-related molecules (4).
大体时间：Changes from baseline serum levels of β-catenin at 12 weeks
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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).
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Changes from baseline serum levels of β-catenin at 12 weeks
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Changes of serum levels of Wnt signaling-related molecules (5).
大体时间：Changes from baseline serum levels of WISP-1 at 12 weeks
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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.).
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Changes from baseline serum levels of WISP-1 at 12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes of serum levels of cancer-related molecules (1).
大体时间：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).
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Changes from baseline serum levels of osteoprotegerin at 12 weeks
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Changes of serum levels of cancer-related molecules (2).
大体时间：Changes from baseline serum levels of osteopontin at 12 weeks
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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).
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Changes from baseline serum levels of osteopontin at 12 weeks
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Changes of serum levels of cancer-related molecules (3).
大体时间：Changes from baseline serum levels of GDF-15 at 12 weeks
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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).
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Changes from baseline serum levels of GDF-15 at 12 weeks
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Changes of serum levels of adipokines (1).
大体时间：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).
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Changes from baseline serum levels of adiponectin at 12 weeks
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Changes of serum levels of adipokines (2).
大体时间：Changes from baseline serum levels of leptin at 12 weeks
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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).
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Changes from baseline serum levels of leptin at 12 weeks
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Changes of serum levels of myokines (1).
大体时间：Changes from baseline serum levels of BDNF at 12 weeks
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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).
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Changes from baseline serum levels of BDNF at 12 weeks
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Changes of serum levels of myokines (2).
大体时间：Changes from baseline serum levels of IL-8 at 12 weeks
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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).
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Changes from baseline serum levels of IL-8 at 12 weeks
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Changes of serum levels of myokines (3).
大体时间：Changes from baseline serum levels of IL-15 at 12 weeks
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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).
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Changes from baseline serum levels of IL-15 at 12 weeks
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Changes of serum levels of myokines (4).
大体时间：Changes from baseline serum levels of FABP3 at 12 weeks
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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).
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Changes from baseline serum levels of FABP3 at 12 weeks
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Changes of serum levels of myokines (5).
大体时间：Changes from baseline serum levels of LIF at 12 weeks
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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).
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Changes from baseline serum levels of LIF at 12 weeks
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Changes of serum levels of myokines (6).
大体时间：Changes from baseline serum levels of follistatin at 12 weeks
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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).
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Changes from baseline serum levels of follistatin at 12 weeks
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Changes of serum levels of myokines (7).
大体时间：Changes from baseline serum levels of fractalkine at 12 weeks
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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).
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Changes from baseline serum levels of fractalkine at 12 weeks
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Changes of serum levels of myokines (8).
大体时间：Changes from baseline serum levels of FGF-21 at 12 weeks
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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).
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Changes from baseline serum levels of FGF-21 at 12 weeks
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Changes of serum levels of myokines (9).
大体时间：Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks
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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).
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Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks
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Changes of serum levels of myokines (10).
大体时间：Changes from baseline serum levels of irisin at 12 weeks
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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).
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Changes from baseline serum levels of irisin at 12 weeks
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Changes of serum levels of inflammatory-related cytokines (1)
大体时间：Changes from baseline serum levels of IL-1 beta at 12 weeks
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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).
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Changes from baseline serum levels of IL-1 beta at 12 weeks
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Changes of serum levels of inflammatory-related cytokines (2)
大体时间：Changes from baseline serum levels of IL-10 at 12 weeks
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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).
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Changes from baseline serum levels of IL-10 at 12 weeks
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Changes of serum levels of inflammatory-related cytokines (3)
大体时间：Changes from baseline serum levels of IL-11 at 12 weeks
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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).
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Changes from baseline serum levels of IL-11 at 12 weeks
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Changes of serum levels of inflammatory-related cytokines (4)
大体时间：Changes from baseline serum levels of TNF-alpha at 12 weeks
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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).
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Changes from baseline serum levels of TNF-alpha at 12 weeks
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Changes of bone mineral density
大体时间：Changes from baseline bone mineral density at 12 weeks
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Bone mineral density is expressed as T-score, which is measured by a compact ultrasonometer at calcaneus (Achilles Express, GE LUNAR Corp., Madison, WI)
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Changes from baseline bone mineral density at 12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：In Deok Kong, Professor、Yonsei University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (预期的)
2023年3月1日
研究完成 (预期的)
2023年12月1日
研究注册日期
首次提交
2016年8月21日
首先提交符合 QC 标准的
2016年9月4日
首次发布 (估计)
2016年9月9日
研究记录更新
最后更新发布 (实际的)
2021年4月8日
上次提交的符合 QC 标准的更新
2021年4月6日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.