Lifestyles Of Health And Sustainability for Breast Cancer Survivors

NCT02895178 | Unknown

• 1 other identifier: LOHAS-BCS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Survivors; Exercise

Outcome Measures

Primary Outcomes (16)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Changes of anthropometric parameters (2).

  BMI calculated as body weight / height (kg per square meters).

  Changes from baseline BMI at 12 weeks

• 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

• 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

• 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

• 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

• 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

• 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

• Changes of serum levels of Wnt signaling-related molecules (4).

  The serum concentration of β-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 β-catenin at 12 weeks

• 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 Outcomes (20)

• Changes of serum levels of cancer-related molecules (1).

  Changes from baseline serum levels of osteoprotegerin at 12 weeks

• Changes of serum levels of cancer-related molecules (2).

  Changes from baseline serum levels of osteopontin at 12 weeks

• Changes of serum levels of cancer-related molecules (3).

  Changes from baseline serum levels of GDF-15 at 12 weeks

• Changes of serum levels of adipokines (1).

  Changes from baseline serum levels of adiponectin at 12 weeks

• Changes of serum levels of adipokines (2).

  Changes from baseline serum levels of leptin at 12 weeks

Study Arms (3)

Exercise in breast cancer survivors

EXPERIMENTAL

Combined aerobic and strength exercise training for 12 weeks under supervision

Behavioral: Combined aerobic and strength exercise training

No exercise in breast cancer survivors

NO INTERVENTION

Lifestyle counseling and standard of care follow up for 12 weeks

Exercise in healthy subjects

SHAM COMPARATOR

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

Behavioral: Combined aerobic and strength exercise training

Interventions

Combined aerobic and strength exercise training 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.

Exercise in breast cancer survivors; Exercise in healthy subjects

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (1)

Center for Exercise medicine; Yonsei University

Wŏnju, Gangwon-do, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 28178355 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• In Deok Kong, Professor

  Yonsei University

  STUDY CHAIR

Central Study Contacts

Jae Seung Chang, Ph.D

CONTACT

+82-33-741-0296; godbless@yonsei.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2016
• First Posted: September 9, 2016
• Study Start: May 1, 2014
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)