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Lifestyles Of Health And Sustainability for Breast Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02895178
Recruitment Status : Active, not recruiting
First Posted : September 9, 2016
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
In Deok Kong, MD, Wonju Severance Christian Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Combined aerobic and strength exercise training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Lifestyle Intervention for Breast Cancer Survivors
Study Start Date : May 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise in breast cancer survivors
Combined aerobic and strength exercise training for 12 weeks under supervision
Behavioral: 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.

No Intervention: No exercise in breast cancer survivors
Lifestyle counseling and standard of care follow up for 12 weeks
Sham Comparator: Exercise in healthy subjects
Age-matched healthy subjects. Combined aerobic and strength exercise training for 12 weeks under supervision
Behavioral: 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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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)

  7. 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).

  8. Changes of anthropometric parameters (2). [ Time Frame: Changes from baseline BMI at 12 weeks ]
    BMI calculated as body weight / height (kg per square meters).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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.).


Secondary Outcome Measures :
  1. Changes of serum levels of cancer-related molecules (1). [ Time Frame: 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).

  2. Changes of serum levels of cancer-related molecules (2). [ Time Frame: 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).

  3. Changes of serum levels of cancer-related molecules (3). [ Time Frame: 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).

  4. Changes of serum levels of adipokines (1). [ Time Frame: 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).

  5. Changes of serum levels of adipokines (2). [ Time Frame: 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).

  6. Changes of serum levels of myokines (1). [ Time Frame: 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).

  7. Changes of serum levels of myokines (2). [ Time Frame: 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).

  8. Changes of serum levels of myokines (3). [ Time Frame: 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).

  9. Changes of serum levels of myokines (4). [ Time Frame: 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).

  10. Changes of serum levels of myokines (5). [ Time Frame: 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).

  11. Changes of serum levels of myokines (6). [ Time Frame: 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).

  12. Changes of serum levels of myokines (7). [ Time Frame: 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).

  13. Changes of serum levels of myokines (8). [ Time Frame: 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).

  14. Changes of serum levels of myokines (9). [ Time Frame: 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).

  15. Changes of serum levels of myokines (10). [ Time Frame: 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).

  16. Changes of serum levels of inflammatory-related cytokines (1) [ Time Frame: 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).

  17. Changes of serum levels of inflammatory-related cytokines (2) [ Time Frame: 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).

  18. Changes of serum levels of inflammatory-related cytokines (3) [ Time Frame: 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).

  19. Changes of serum levels of inflammatory-related cytokines (4) [ Time Frame: 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).

  20. Changes of bone mineral density [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895178


Locations
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Korea, Republic of
Center for Exercise medicine; Yonsei University
Wonju, Gangwon-do, Korea, Republic of
Sponsors and Collaborators
Wonju Severance Christian Hospital
Investigators
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Study Chair: In Deok Kong, Professor Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: In Deok Kong, MD, Professor, Wonju Severance Christian Hospital
ClinicalTrials.gov Identifier: NCT02895178     History of Changes
Other Study ID Numbers: LOHAS-BCS
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by In Deok Kong, MD, Wonju Severance Christian Hospital:
Breast cancer
Survivors
Exercise

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases