Lifestyles Of Health And Sustainability for Breast Cancer Survivors

  • STATUS
    Recruiting
  • End date
    Dec 15, 2023
  • participants needed
    60
  • sponsor
    Wonju Severance Christian Hospital
Updated on 15 April 2021
mastectomy
lumpectomy
adjuvant chemotherapy
immunostimulant

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-1), IL-10, IL-11, tumor necrosis factor alpha (TNF), 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.

Details
Condition Breast Cancer, Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Combined aerobic and strength exercise training
Clinical Study IdentifierNCT02895178
SponsorWonju Severance Christian Hospital
Last Modified on15 April 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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