Lifestyles Of Health And Sustainability for Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Lifestyle Intervention for Breast Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02895178
• Other study ID #: LOHAS-BCS
• Status: Recruiting
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2023

Study information

• Verified date: April 2021
• Source: Wonju Severance Christian Hospital
• Contact: Jae Seung Chang, Ph.D
• Phone: +82-33-741-0296
• Email: godbless[@]yonsei.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Center for Exercise medicine; Yonsei University	Wonju	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Changes from baseline aerobic capacity at 12 weeks
Primary	Changes of health-related physical fitness components (2).	Muscular endurance is assessed using sit-up test for 30 seconds (the maximum number of repetitions).	Changes from baseline muscular endurance at 12 weeks
Primary	Changes of health-related physical fitness components (3).	Muscular strength is assessed by the maximum voluntary strength of handgrip (kg).	Changes from baseline muscular strength at 12 weeks
Primary	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).	Changes from baseline muscular power at 12 weeks
Primary	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).	Changes from baseline agility at 12 weeks
Primary	Changes of health-related physical fitness components (6).	Flexibility is assessed using sit and reach test (the greater distance of two trials, cm)	Changes from baseline flexibility at 12 weeks
Primary	Changes of anthropometric parameters (1).	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
Primary	Changes of anthropometric parameters (2).	BMI calculated as body weight / height (kg per square meters).	Changes from baseline BMI at 12 weeks
Primary	Changes of body composition parameters (1).	Body fat mass is measured by a bio-impedance analyzer (expressed as kg).	Changes from baseline body fat mass at 12 weeks
Primary	Changes of body composition parameters (2).	Lean body mass is measured by a bio-impedance analyzer (expressed as kg).	Changes from baseline lean body mass at 12 weeks
Primary	Changes of body composition parameters (3).	Percentage body fat is calculated as body fat mass (kg) divided by weight (kg).	Changes from baseline percentage body fat at 12 weeks
Primary	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).	Changes from baseline serum levels of DKK1 at 12 weeks
Primary	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).	Changes from baseline serum levels of Sclerostin at 12 weeks
Primary	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.).	Changes from baseline serum levels of SFRP1 at 12 weeks
Primary	Changes of serum levels of Wnt signaling-related molecules (4).	The serum concentration of ß-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 ß-catenin at 12 weeks
Primary	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.).	Changes from baseline serum levels of WISP-1 at 12 weeks
Secondary	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).	Changes from baseline serum levels of osteoprotegerin at 12 weeks
Secondary	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).	Changes from baseline serum levels of osteopontin at 12 weeks
Secondary	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).	Changes from baseline serum levels of GDF-15 at 12 weeks
Secondary	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).	Changes from baseline serum levels of adiponectin at 12 weeks
Secondary	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).	Changes from baseline serum levels of leptin at 12 weeks
Secondary	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).	Changes from baseline serum levels of BDNF at 12 weeks
Secondary	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).	Changes from baseline serum levels of IL-8 at 12 weeks
Secondary	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).	Changes from baseline serum levels of IL-15 at 12 weeks
Secondary	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).	Changes from baseline serum levels of FABP3 at 12 weeks
Secondary	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).	Changes from baseline serum levels of LIF at 12 weeks
Secondary	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).	Changes from baseline serum levels of follistatin at 12 weeks
Secondary	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).	Changes from baseline serum levels of fractalkine at 12 weeks
Secondary	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).	Changes from baseline serum levels of FGF-21 at 12 weeks
Secondary	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).	Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks
Secondary	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).	Changes from baseline serum levels of irisin at 12 weeks
Secondary	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).	Changes from baseline serum levels of IL-1 beta at 12 weeks
Secondary	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).	Changes from baseline serum levels of IL-10 at 12 weeks
Secondary	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).	Changes from baseline serum levels of IL-11 at 12 weeks
Secondary	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).	Changes from baseline serum levels of TNF-alpha at 12 weeks
Secondary	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)	Changes from baseline bone mineral density at 12 weeks