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Follistatin 344

FS-344, Activin-Binding Protein, FST344

Quick Stats
Studies 2
Trials 73
Overview Studies Clinical Trials
Unknown NA INTERVENTIONAL NCT02895178

Lifestyles Of Health And Sustainability for Breast Cancer Survivors

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: Combined aerobic and strength exercise training
Type: BEHAVIORAL
Description: 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.

Primary Outcomes

Measure: Changes of health-related physical fitness components (1).
TimeFrame: Changes from baseline aerobic capacity at 12 weeks
Description: Aerobic capacity is assessed using multi-stage 20 meters shuttle run test (the maximum number of repetitions).
Measure: Changes of health-related physical fitness components (2).
TimeFrame: Changes from baseline muscular endurance at 12 weeks
Description: Muscular endurance is assessed using sit-up test for 30 seconds (the maximum number of repetitions).
Measure: Changes of health-related physical fitness components (3).
TimeFrame: Changes from baseline muscular strength at 12 weeks
Description: Muscular strength is assessed by the maximum voluntary strength of handgrip (kg).
Measure: Changes of health-related physical fitness components (4).
TimeFrame: Changes from baseline muscular power at 12 weeks
Description: Muscular power is assessed using standing long jump test (the maximum horizontal distance of two trials, cm).
Measure: Changes of health-related physical fitness components (5).
TimeFrame: Changes from baseline agility at 12 weeks
Description: Agility is assessed using 10 meters agility shuttle run test (the time taken to complete a 10 meters course is recorded, seconds).
Measure: Changes of health-related physical fitness components (6).
TimeFrame: Changes from baseline flexibility at 12 weeks
Description: Flexibility is assessed using sit and reach test (the greater distance of two trials, cm)
Measure: Changes of anthropometric parameters (1).
TimeFrame: Changes from baseline waist circumference at 12 weeks
Description: Waist circumference is measured at the midpoint between the lower rib margin and the iliac crest (expressed in cm).
Measure: Changes of anthropometric parameters (2).
TimeFrame: Changes from baseline BMI at 12 weeks
Description: BMI calculated as body weight / height (kg per square meters).
Measure: Changes of body composition parameters (1).
TimeFrame: Changes from baseline body fat mass at 12 weeks
Description: Body fat mass is measured by a bio-impedance analyzer (expressed as kg).
Measure: Changes of body composition parameters (2).
TimeFrame: Changes from baseline lean body mass at 12 weeks
Description: Lean body mass is measured by a bio-impedance analyzer (expressed as kg).
Measure: Changes of body composition parameters (3).
TimeFrame: Changes from baseline percentage body fat at 12 weeks
Description: Percentage body fat is calculated as body fat mass (kg) divided by weight (kg).
Measure: Changes of serum levels of Wnt signaling-related molecules (1).
TimeFrame: Changes from baseline serum levels of DKK1 at 12 weeks
Description: 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).
Measure: Changes of serum levels of Wnt signaling-related molecules (2).
TimeFrame: Changes from baseline serum levels of Sclerostin at 12 weeks
Description: 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).
Measure: Changes of serum levels of Wnt signaling-related molecules (3).
TimeFrame: Changes from baseline serum levels of SFRP1 at 12 weeks
Description: 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.).
Measure: Changes of serum levels of Wnt signaling-related molecules (4).
TimeFrame: Changes from baseline serum levels of β-catenin at 12 weeks
Description: 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).
Measure: Changes of serum levels of Wnt signaling-related molecules (5).
TimeFrame: Changes from baseline serum levels of WISP-1 at 12 weeks
Description: 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.).

Trial Information

NCT ID

NCT02895178

Status

Unknown

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Wonju Severance Christian Hospital

Last Updated

December 15, 2025

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