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Lifestyles Of Health And Sustainability for Breast Cancer Survivors

6 de abril de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jae Seung Chang, Ph.D
  • Número de teléfono: +82-33-741-0296
  • Correo electrónico: godbless@yonsei.ac.kr

Ubicaciones de estudio

  • Corea, república de
    • Gangwon-do
      • Wonju, Gangwon-do, Corea, república de
        • Reclutamiento
        • Center for Exercise medicine; Yonsei University
        • Contacto:
          • Jae Seung Chang, Ph.D
          • Número de teléfono: +82-70-8826-0292
          • Correo electrónico: godbless@yonsei.ac.kr
        • Investigador principal:
          • Jae Seung Chang, Ph.D

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 64 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Exercise in breast cancer survivors
Combined aerobic and strength exercise training for 12 weeks under supervision
Conductual: 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.
Sin intervención: No exercise in breast cancer survivors
Lifestyle counseling and standard of care follow up for 12 weeks
Comparador falso: Exercise in healthy subjects
Age-matched healthy subjects. Combined aerobic and strength exercise training for 12 weeks under supervision
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes of health-related physical fitness components (1).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes of serum levels of cancer-related molecules (1).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Wonju Severance Christian Hospital

Investigadores

  • Silla de estudio: In Deok Kong, Professor, Yonsei University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2014

Finalización primaria (Anticipado)

1 de marzo de 2023

Finalización del estudio (Anticipado)

1 de diciembre de 2023

Fechas de registro del estudio

Enviado por primera vez

21 de agosto de 2016

Primero enviado que cumplió con los criterios de control de calidad

4 de septiembre de 2016

Publicado por primera vez (Estimar)

9 de septiembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de abril de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

6 de abril de 2021

Última verificación

1 de abril de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • LOHAS-BCS

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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