Breast CancerNCT02895178
Lifestyles Of Health And Sustainability for Breast Cancer Survivors
A study testing Combined aerobic and strength exercise training in people with Breast Cancer, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Combined aerobic and strength exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Center for Exercise medicine; Yonsei University
Wŏnju, Gangwon-do
Jae Seung Chang, Ph.D, +82-70-8826-0292, godbless@yonsei.ac.kr
Jae Seung Chang, Ph.D
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Conditions
- Breast Cancer
- Being tested
- Combined aerobic and strength exercise training
- Keywords
- Breast cancer, Survivors, Exercise
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined aerobic and strength exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise in breast cancer survivors | Experimental | Combined aerobic and strength exercise training for 12 weeks under supervision Receives: Behavioral: Combined aerobic and strength exercise training |
| No exercise in breast cancer survivors | No intervention | Lifestyle counseling and standard of care follow up for 12 weeks |
| Exercise in healthy subjects | Sham comparator | Age-matched healthy subjects. Combined aerobic and strength exercise training for 12 weeks under supervision Receives: Behavioral: Combined aerobic and strength exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of health-related physical fitness components (1).
Aerobic capacity is assessed using multi-stage 20 meters shuttle run test (the maximum number of repetitions).
Measured: Changes from baseline aerobic capacity at 12 weeks
Changes of health-related physical fitness components (2).
Muscular endurance is assessed using sit-up test for 30 seconds (the maximum number of repetitions).
Measured: Changes from baseline muscular endurance at 12 weeks
Changes of health-related physical fitness components (3).
Muscular strength is assessed by the maximum voluntary strength of handgrip (kg).
Measured: Changes from baseline muscular strength at 12 weeks
Changes of health-related physical fitness components (4).
Muscular power is assessed using standing long jump test (the maximum horizontal distance of two trials, cm).
Measured: Changes from baseline muscular power at 12 weeks
Changes of health-related physical fitness components (5).
Agility is assessed using 10 meters agility shuttle run test (the time taken to complete a 10 meters course is recorded, seconds).
Measured: Changes from baseline agility at 12 weeks
Changes of health-related physical fitness components (6).
Flexibility is assessed using sit and reach test (the greater distance of two trials, cm)
Measured: Changes from baseline flexibility at 12 weeks
Changes of anthropometric parameters (1).
Waist circumference is measured at the midpoint between the lower rib margin and the iliac crest (expressed in cm).
Measured: Changes from baseline waist circumference at 12 weeks
Changes of anthropometric parameters (2).
BMI calculated as body weight / height (kg per square meters).
Measured: Changes from baseline BMI at 12 weeks
Changes of body composition parameters (1).
Body fat mass is measured by a bio-impedance analyzer (expressed as kg).
Measured: Changes from baseline body fat mass at 12 weeks
Changes of body composition parameters (2).
Lean body mass is measured by a bio-impedance analyzer (expressed as kg).
Measured: Changes from baseline lean body mass at 12 weeks
Changes of body composition parameters (3).
Percentage body fat is calculated as body fat mass (kg) divided by weight (kg).
Measured: Changes from baseline percentage body fat at 12 weeks
Changes of serum levels of Wnt signaling-related molecules (1).
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).
Measured: Changes from baseline serum levels of DKK1 at 12 weeks
Changes of serum levels of Wnt signaling-related molecules (2).
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).
Measured: Changes from baseline serum levels of Sclerostin at 12 weeks
Changes of serum levels of Wnt signaling-related molecules (3).
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.).
Measured: Changes from baseline serum levels of SFRP1 at 12 weeks
Changes of serum levels of Wnt signaling-related molecules (4).
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).
Measured: Changes from baseline serum levels of β-catenin at 12 weeks
Changes of serum levels of Wnt signaling-related molecules (5).
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.).
Measured: Changes from baseline serum levels of WISP-1 at 12 weeks
Secondary outcomes (20)
Changes of serum levels of cancer-related molecules (1).
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).
Measured: Changes from baseline serum levels of osteoprotegerin at 12 weeks
Changes of serum levels of cancer-related molecules (2).
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).
Measured: Changes from baseline serum levels of osteopontin at 12 weeks
Changes of serum levels of cancer-related molecules (3).
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).
Measured: Changes from baseline serum levels of GDF-15 at 12 weeks
Changes of serum levels of adipokines (1).
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).
Measured: Changes from baseline serum levels of adiponectin at 12 weeks
Changes of serum levels of adipokines (2).
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).
Measured: Changes from baseline serum levels of leptin at 12 weeks
Changes of serum levels of myokines (1).
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).
Measured: Changes from baseline serum levels of BDNF at 12 weeks
Changes of serum levels of myokines (2).
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).
Measured: Changes from baseline serum levels of IL-8 at 12 weeks
Changes of serum levels of myokines (3).
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).
Measured: Changes from baseline serum levels of IL-15 at 12 weeks
Changes of serum levels of myokines (4).
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).
Measured: Changes from baseline serum levels of FABP3 at 12 weeks
Changes of serum levels of myokines (5).
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).
Measured: Changes from baseline serum levels of LIF at 12 weeks
Changes of serum levels of myokines (6).
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).
Measured: Changes from baseline serum levels of follistatin at 12 weeks
Changes of serum levels of myokines (7).
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).
Measured: Changes from baseline serum levels of fractalkine at 12 weeks
Changes of serum levels of myokines (8).
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).
Measured: Changes from baseline serum levels of FGF-21 at 12 weeks
Changes of serum levels of myokines (9).
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).
Measured: Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks
Changes of serum levels of myokines (10).
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).
Measured: Changes from baseline serum levels of irisin at 12 weeks
Changes of serum levels of inflammatory-related cytokines (1)
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).
Measured: Changes from baseline serum levels of IL-1 beta at 12 weeks
Changes of serum levels of inflammatory-related cytokines (2)
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).
Measured: Changes from baseline serum levels of IL-10 at 12 weeks
Changes of serum levels of inflammatory-related cytokines (3)
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).
Measured: Changes from baseline serum levels of IL-11 at 12 weeks
Changes of serum levels of inflammatory-related cytokines (4)
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).
Measured: Changes from baseline serum levels of TNF-alpha at 12 weeks
Changes of bone mineral density
Bone mineral density is expressed as T-score, which is measured by a compact ultrasonometer at calcaneus (Achilles Express, GE LUNAR Corp., Madison, WI)
Measured: Changes from baseline bone mineral density at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startMay 2014
- Primary completionMar 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Deok Kong, MD, Wonju Severance Christian Hospital
- Investigators
- In Deok Kong, Professor, Study chair, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895178
- Sponsor's protocol ID
- LOHAS-BCS
- Status last verified
- Apr 2021
- First submitted
- 21 Aug 2016
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim TH, Chang JS, Park KS, Park J, Kim N, Lee JI, Kong ID. Effects of exercise training on circulating levels of Dickkpof-1 and secreted frizzled-related protein-1 in breast cancer survivors: A pilot single-blind randomized controlled trial. PLoS One. 2017 Feb 8;12(2):e0171771. doi: 10.1371/journal.pone.0171771. eCollection 2017.
PubMed 28178355
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02895178
- Acronym / sponsor ID
- LOHAS-BCS
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Survivors, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise in breast cancer survivors | Experimental | Behavioral: Combined aerobic and strength exercise trainingCombined aerobic and strength exercise training for 12 weeks under supervision |
| No exercise in breast cancer survivors | No intervention | –Lifestyle counseling and standard of care follow up for 12 weeks |
| Exercise in healthy subjects | Sham comparator | Behavioral: Combined aerobic and strength exercise trainingAge-matched healthy subjects. Combined aerobic and strength exercise training for 12 weeks under supervision |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined aerobic and strength exercise trainingSubjects 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. | Behavioural | Exercise in breast cancer survivors, Exercise in healthy subjects |
Primary outcome
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 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 (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 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 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 (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 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 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).
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 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 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 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.).
20 secondary outcomes
Changes of serum levels of cancer-related molecules (1).
Time frame: Changes from baseline serum levels of osteoprotegerin at 12 weeks
Changes of serum levels of cancer-related molecules (2).
Time frame: Changes from baseline serum levels of osteopontin at 12 weeks
Changes of serum levels of cancer-related molecules (3).
Time frame: Changes from baseline serum levels of GDF-15 at 12 weeks
Changes of serum levels of adipokines (1).
Time frame: Changes from baseline serum levels of adiponectin at 12 weeks
Changes of serum levels of adipokines (2).
Time frame: Changes from baseline serum levels of leptin at 12 weeks
Changes of serum levels of myokines (1).
Time frame: Changes from baseline serum levels of BDNF at 12 weeks
Changes of serum levels of myokines (2).
Time frame: Changes from baseline serum levels of IL-8 at 12 weeks
Changes of serum levels of myokines (3).
Time frame: Changes from baseline serum levels of IL-15 at 12 weeks
Changes of serum levels of myokines (4).
Time frame: Changes from baseline serum levels of FABP3 at 12 weeks
Changes of serum levels of myokines (5).
Time frame: Changes from baseline serum levels of LIF at 12 weeks
Changes of serum levels of myokines (6).
Time frame: Changes from baseline serum levels of follistatin at 12 weeks
Changes of serum levels of myokines (7).
Time frame: Changes from baseline serum levels of fractalkine at 12 weeks
Changes of serum levels of myokines (8).
Time frame: Changes from baseline serum levels of FGF-21 at 12 weeks
Changes of serum levels of myokines (9).
Time frame: Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks
Changes of serum levels of myokines (10).
Time frame: Changes from baseline serum levels of irisin at 12 weeks
Changes of serum levels of inflammatory-related cytokines (1)
Time frame: Changes from baseline serum levels of IL-1 beta at 12 weeks
Changes of serum levels of inflammatory-related cytokines (2)
Time frame: Changes from baseline serum levels of IL-10 at 12 weeks
Changes of serum levels of inflammatory-related cytokines (3)
Time frame: Changes from baseline serum levels of IL-11 at 12 weeks
Changes of serum levels of inflammatory-related cytokines (4)
Time frame: Changes from baseline serum levels of TNF-alpha at 12 weeks
Changes of bone mineral density
Time frame: Changes from baseline bone mineral density at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Derived from this study: PubMed 28178355Kim TH, Chang JS, Park KS, Park J, Kim N, Lee JI, Kong ID. Effects of exercise training on circulating levels of Dickkpof-1 and secreted frizzled-related protein-1 in breast cancer survivors: A pilot single-blind randomized controlled trial. PLoS One. 2017 Feb 8;12(2):e0171771. doi: 10.1371/journal.pone.0171771. eCollection 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Deok Kong, Professor study chair
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined aerobic and strength exercise training in people with Breast Cancer, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Seung Chang, Ph.D (+82-33-741-0296, godbless@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of health-related physical fitness components (1). (time frame: Changes from baseline aerobic capacity at 12 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02895178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.