Lifestyles Of Health And Sustainability for Breast Cancer Survivors

NCT ID: NCT02895178

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2023-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Exercise in breast cancer survivors

Combined aerobic and strength exercise training for 12 weeks under supervision

Group Type: EXPERIMENTAL

Combined aerobic and strength exercise training

Intervention Type: BEHAVIORAL

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.

No exercise in breast cancer survivors

Lifestyle counseling and standard of care follow up for 12 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise in healthy subjects

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

Group Type: SHAM_COMPARATOR

Combined aerobic and strength exercise training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wonju Severance Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

In Deok Kong, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In Deok Kong, Professor

Role: STUDY_CHAIR

Yonsei University

Locations

Center for Exercise medicine; Yonsei University

Wŏnju, Gangwon-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jae Seung Chang, Ph.D

Role: CONTACT

godbless@yonsei.ac.kr

+82-33-741-0296

Facility Contacts

Jae Seung Chang, Ph.D

Role: primary

godbless@yonsei.ac.kr

+82-70-8826-0292

References

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.

Reference Type: DERIVED

PMID: 28178355 (View on PubMed)

Other Identifiers

LOHAS-BCS

Identifier Type: -

Identifier Source: org_study_id