Clinical trial NCT02895178: Lifestyles Of Health And Sustainability for Breast Cancer Survivors
Official title: Lifestyle Intervention for Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Survivors
Exercise
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Changes of health-related physical fitness components (1).
timeFrame: Changes from baseline aerobic capacity at 12 weeks
measure: Changes of health-related physical fitness components (2).
timeFrame: Changes from baseline muscular endurance at 12 weeks
measure: Changes of health-related physical fitness components (3).
timeFrame: Changes from baseline muscular strength at 12 weeks
measure: Changes of health-related physical fitness components (4).
timeFrame: Changes from baseline muscular power at 12 weeks
measure: Changes of health-related physical fitness components (5).
timeFrame: Changes from baseline agility at 12 weeks
measure: Changes of health-related physical fitness components (6).
timeFrame: Changes from baseline flexibility at 12 weeks
measure: Changes of anthropometric parameters (1).
timeFrame: Changes from baseline waist circumference at 12 weeks
measure: Changes of anthropometric parameters (2).
timeFrame: Changes from baseline BMI at 12 weeks
measure: Changes of body composition parameters (1).
timeFrame: Changes from baseline body fat mass at 12 weeks
measure: Changes of body composition parameters (2).
timeFrame: Changes from baseline lean body mass at 12 weeks
measure: Changes of body composition parameters (3).
timeFrame: Changes from baseline percentage body fat at 12 weeks
measure: Changes of serum levels of Wnt signaling-related molecules (1).
timeFrame: Changes from baseline serum levels of DKK1 at 12 weeks
measure: Changes of serum levels of Wnt signaling-related molecules (2).
timeFrame: Changes from baseline serum levels of Sclerostin at 12 weeks
measure: Changes of serum levels of Wnt signaling-related molecules (3).
timeFrame: Changes from baseline serum levels of SFRP1 at 12 weeks
measure: Changes of serum levels of Wnt signaling-related molecules (4).
timeFrame: Changes from baseline serum levels of β-catenin at 12 weeks
measure: Changes of serum levels of Wnt signaling-related molecules (5).
timeFrame: Changes from baseline serum levels of WISP-1 at 12 weeks
Secondary outcomes:
measure: Changes of serum levels of cancer-related molecules (1).
timeFrame: Changes from baseline serum levels of osteoprotegerin at 12 weeks
measure: Changes of serum levels of cancer-related molecules (2).
timeFrame: Changes from baseline serum levels of osteopontin at 12 weeks
measure: Changes of serum levels of cancer-related molecules (3).
timeFrame: Changes from baseline serum levels of GDF-15 at 12 weeks
measure: Changes of serum levels of adipokines (1).
timeFrame: Changes from baseline serum levels of adiponectin at 12 weeks
measure: Changes of serum levels of adipokines (2).
timeFrame: Changes from baseline serum levels of leptin at 12 weeks
measure: Changes of serum levels of myokines (1).
timeFrame: Changes from baseline serum levels of BDNF at 12 weeks
measure: Changes of serum levels of myokines (2).
timeFrame: Changes from baseline serum levels of IL-8 at 12 weeks
measure: Changes of serum levels of myokines (3).
timeFrame: Changes from baseline serum levels of IL-15 at 12 weeks
measure: Changes of serum levels of myokines (4).
timeFrame: Changes from baseline serum levels of FABP3 at 12 weeks
measure: Changes of serum levels of myokines (5).
timeFrame: Changes from baseline serum levels of LIF at 12 weeks
measure: Changes of serum levels of myokines (6).
timeFrame: Changes from baseline serum levels of follistatin at 12 weeks
measure: Changes of serum levels of myokines (7).
timeFrame: Changes from baseline serum levels of fractalkine at 12 weeks
measure: Changes of serum levels of myokines (8).
timeFrame: Changes from baseline serum levels of FGF-21 at 12 weeks
measure: Changes of serum levels of myokines (9).
timeFrame: Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks
measure: Changes of serum levels of myokines (10).
timeFrame: Changes from baseline serum levels of irisin at 12 weeks
measure: Changes of serum levels of inflammatory-related cytokines (1)
timeFrame: Changes from baseline serum levels of IL-1 beta at 12 weeks
measure: Changes of serum levels of inflammatory-related cytokines (2)
timeFrame: Changes from baseline serum levels of IL-10 at 12 weeks
measure: Changes of serum levels of inflammatory-related cytokines (3)
timeFrame: Changes from baseline serum levels of IL-11 at 12 weeks
measure: Changes of serum levels of inflammatory-related cytokines (4)
timeFrame: Changes from baseline serum levels of TNF-alpha at 12 weeks
measure: Changes of bone mineral density
timeFrame: Changes from baseline bone mineral density at 12 weeks
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Center for Exercise medicine; Yonsei University
state: Gangwon-do
Study officials:
affiliation: Yonsei University
name: In Deok Kong, Professor
role: STUDY_CHAIR
References:
citation: 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.