Lifestyles Of Health And Sustainability for Breast Cancer Survivors

Wonju Severance Christian Hospital

Status: Unknown

Conditions: Breast Cancer

Treatments: Behavioral: Combined aerobic and strength exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02895178

LOHAS-BCS

Details and patient eligibility

About

The purpose of this study is to examine the effects of exercise program on health-related physical fitness and biomarkers among breast cancer survivors.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Exercise in breast cancer survivors

Experimental group

Description:

Combined aerobic and strength exercise training for 12 weeks under supervision

Treatment:

Behavioral: Combined aerobic and strength exercise training

No exercise in breast cancer survivors

No Intervention group

Description:

Lifestyle counseling and standard of care follow up for 12 weeks

Exercise in healthy subjects

Sham Comparator group

Description:

Age-matched healthy subjects. Combined aerobic and strength exercise training for 12 weeks under supervision

Treatment:

Behavioral: Combined aerobic and strength exercise training