Lifestyle Intervention for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes of health-related physical fitness components (3).
研究概览
简要总结
The purpose of this study is to examine the effects of exercise program on health-related physical fitness and biomarkers among breast cancer survivors.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes of health-related physical fitness components (3).
时间窗: Changes from baseline muscular strength at 12 weeks
Muscular strength is assessed by the maximum voluntary strength of handgrip (kg).
Changes of serum levels of Wnt signaling-related molecules (2).
时间窗: 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 of health-related physical fitness components (2).
时间窗: 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 of health-related physical fitness components (4).
时间窗: 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 of health-related physical fitness components (5).
时间窗: 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 of serum levels of Wnt signaling-related molecules (1).
时间窗: 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 of health-related physical fitness components (1).
时间窗: 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 of anthropometric parameters (1).
时间窗: 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 of serum levels of Wnt signaling-related molecules (3).
时间窗: 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 of serum levels of Wnt signaling-related molecules (4).
时间窗: 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 of health-related physical fitness components (6).
时间窗: Changes from baseline flexibility at 12 weeks
Flexibility is assessed using sit and reach test (the greater distance of two trials, cm)
Changes of anthropometric parameters (2).
时间窗: Changes from baseline BMI at 12 weeks
BMI calculated as body weight / height (kg per square meters).
Changes of body composition parameters (1).
时间窗: Changes from baseline body fat mass at 12 weeks
Body fat mass is measured by a bio-impedance analyzer (expressed as kg).
Changes of serum levels of Wnt signaling-related molecules (5).
时间窗: 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 of body composition parameters (2).
时间窗: Changes from baseline lean body mass at 12 weeks
Lean body mass is measured by a bio-impedance analyzer (expressed as kg).
Changes of body composition parameters (3).
时间窗: Changes from baseline percentage body fat at 12 weeks
Percentage body fat is calculated as body fat mass (kg) divided by weight (kg).
次要结局
- Changes of serum levels of adipokines (1).(Changes from baseline serum levels of adiponectin at 12 weeks)
- Changes of serum levels of myokines (3).(Changes from baseline serum levels of IL-15 at 12 weeks)
- Changes of serum levels of cancer-related molecules (1).(Changes from baseline serum levels of osteoprotegerin at 12 weeks)
- Changes of serum levels of myokines (4).(Changes from baseline serum levels of FABP3 at 12 weeks)
- Changes of serum levels of myokines (6).(Changes from baseline serum levels of follistatin at 12 weeks)
- Changes of serum levels of inflammatory-related cytokines (1)(Changes from baseline serum levels of IL-1 beta at 12 weeks)
- Changes of serum levels of adipokines (2).(Changes from baseline serum levels of leptin at 12 weeks)
- Changes of serum levels of myokines (2).(Changes from baseline serum levels of IL-8 at 12 weeks)
- Changes of serum levels of myokines (5).(Changes from baseline serum levels of LIF at 12 weeks)
- Changes of serum levels of myokines (8).(Changes from baseline serum levels of FGF-21 at 12 weeks)
- Changes of serum levels of inflammatory-related cytokines (2)(Changes from baseline serum levels of IL-10 at 12 weeks)
- Changes of serum levels of cancer-related molecules (2).(Changes from baseline serum levels of osteopontin at 12 weeks)
- Changes of serum levels of cancer-related molecules (3).(Changes from baseline serum levels of GDF-15 at 12 weeks)
- Changes of serum levels of myokines (1).(Changes from baseline serum levels of BDNF at 12 weeks)
- Changes of serum levels of myokines (9).(Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks)
- Changes of serum levels of myokines (10).(Changes from baseline serum levels of irisin at 12 weeks)
- Changes of serum levels of inflammatory-related cytokines (3)(Changes from baseline serum levels of IL-11 at 12 weeks)
- Changes of serum levels of inflammatory-related cytokines (4)(Changes from baseline serum levels of TNF-alpha at 12 weeks)
- Changes of serum levels of myokines (7).(Changes from baseline serum levels of fractalkine at 12 weeks)
- Changes of bone mineral density(Changes from baseline bone mineral density at 12 weeks)
研究者
In Deok Kong, MD
Professor
Wonju Severance Christian Hospital