Lifestyle Intervention for Breast Cancer Survivors
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Wonju Severance Christian Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes of health-related physical fitness components (3).
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to examine the effects of exercise program on health-related physical fitness and biomarkers among breast cancer survivors.
Detailed Description
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.
Investigators
In Deok Kong, MD
Professor
Wonju Severance Christian Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes of health-related physical fitness components (3).
Time Frame: 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).
Time Frame: 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).
Time Frame: 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).
Time Frame: 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).
Time Frame: 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).
Time Frame: 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).
Time Frame: 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).
Time Frame: 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).
Time Frame: 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).
Time Frame: 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).
Time Frame: 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).
Time Frame: Changes from baseline BMI at 12 weeks
BMI calculated as body weight / height (kg per square meters).
Changes of body composition parameters (1).
Time Frame: 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).
Time Frame: 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).
Time Frame: 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).
Time Frame: Changes from baseline percentage body fat at 12 weeks
Percentage body fat is calculated as body fat mass (kg) divided by weight (kg).
Secondary Outcomes
- 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)