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Lifestyles Of Health And Sustainability for Breast Cancer Survivors

2021년 4월 6일 업데이트: In Deok Kong, MD, Wonju Severance Christian Hospital

Lifestyle Intervention for Breast Cancer Survivors

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

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대한민국
    • Gangwon-do
      • Wonju, Gangwon-do, 대한민국
        • 모병
        • Center for Exercise medicine; Yonsei University
        • 연락하다:
        • 수석 연구원:
          • Jae Seung Chang, Ph.D

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Exercise in breast cancer survivors
Combined aerobic and strength exercise training for 12 weeks under supervision
행동: 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.
간섭 없음: No exercise in breast cancer survivors
Lifestyle counseling and standard of care follow up for 12 weeks
가짜 비교기: Exercise in healthy subjects
Age-matched healthy subjects. Combined aerobic and strength exercise training for 12 weeks under supervision
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes of health-related physical fitness components (1).
기간: Changes from baseline aerobic capacity at 12 weeks
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).
기간: Changes from baseline muscular endurance at 12 weeks
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).
기간: Changes from baseline muscular strength at 12 weeks
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).
기간: Changes from baseline muscular power at 12 weeks
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).
기간: Changes from baseline agility at 12 weeks
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).
기간: Changes from baseline flexibility at 12 weeks
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).
기간: Changes from baseline waist circumference at 12 weeks
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).
기간: Changes from baseline BMI at 12 weeks
BMI calculated as body weight / height (kg per square meters).
Changes from baseline BMI at 12 weeks
Changes of body composition parameters (1).
기간: Changes from baseline body fat mass at 12 weeks
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).
기간: Changes from baseline lean body mass at 12 weeks
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).
기간: Changes from baseline percentage body fat at 12 weeks
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).
기간: Changes from baseline serum levels of DKK1 at 12 weeks
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).
기간: Changes from baseline serum levels of Sclerostin at 12 weeks
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).
기간: Changes from baseline serum levels of SFRP1 at 12 weeks
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).
기간: Changes from baseline serum levels of β-catenin at 12 weeks
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).
기간: Changes from baseline serum levels of WISP-1 at 12 weeks
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

2차 결과 측정

결과 측정
측정값 설명
기간
Changes of serum levels of cancer-related molecules (1).
기간: Changes from baseline serum levels of osteoprotegerin at 12 weeks
The serum concentration of osteoprotegerin is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 3.62 pg/ml; Standard curve range, 81.4 - 19,770 pg/ml, R&D systems).
Changes from baseline serum levels of osteoprotegerin at 12 weeks
Changes of serum levels of cancer-related molecules (2).
기간: Changes from baseline serum levels of osteopontin at 12 weeks
The serum concentration of osteopontin is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 413 pg/ml; Standard curve range, 3.4 - 826.9 ng/ml, R&D systems).
Changes from baseline serum levels of osteopontin at 12 weeks
Changes of serum levels of cancer-related molecules (3).
기간: Changes from baseline serum levels of GDF-15 at 12 weeks
The serum concentration of GDF-15 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 1.2 pg/ml; Standard curve range, 34 - 8,270 pg/ml, R&D systems).
Changes from baseline serum levels of GDF-15 at 12 weeks
Changes of serum levels of adipokines (1).
기간: Changes from baseline serum levels of adiponectin at 12 weeks
The serum concentration of adiponectin is measured by commercial enzyme-linked immunosorbent assay kits (Minimal detectable density, 0.891 ng/ml; Standard curve range, 3.9 - 250 ng/ml, R&D systems).
Changes from baseline serum levels of adiponectin at 12 weeks
Changes of serum levels of adipokines (2).
기간: Changes from baseline serum levels of leptin at 12 weeks
The serum concentration of leptin is measured by commercial enzyme-linked immunosorbent assay kits (Minimal detectable density, 7.8 pg/ml; Standard curve range, 15.6 - 1,000 ng/ml, R&D systems).
Changes from baseline serum levels of leptin at 12 weeks
Changes of serum levels of myokines (1).
기간: Changes from baseline serum levels of BDNF at 12 weeks
The serum concentration of BDNF is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 0.32 pg/ml; Standard curve range, 10.9 - 2,650 pg/ml, R&D systems).
Changes from baseline serum levels of BDNF at 12 weeks
Changes of serum levels of myokines (2).
기간: Changes from baseline serum levels of IL-8 at 12 weeks
The serum concentration of IL-8 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 1.8 pg/ml; Standard curve range, 8.19 - 1,990 pg/ml, R&D systems).
Changes from baseline serum levels of IL-8 at 12 weeks
Changes of serum levels of myokines (3).
기간: Changes from baseline serum levels of IL-15 at 12 weeks
The serum concentration of IL-15 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 1.01 pg/ml; Standard curve range, 7.7 - 18,700 pg/ml, R&D systems).
Changes from baseline serum levels of IL-15 at 12 weeks
Changes of serum levels of myokines (4).
기간: Changes from baseline serum levels of FABP3 at 12 weeks
The serum concentration of FABP3 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 472 pg/ml; Standard curve range, 1.3 - 312.2 ng/ml, R&D systems).
Changes from baseline serum levels of FABP3 at 12 weeks
Changes of serum levels of myokines (5).
기간: Changes from baseline serum levels of LIF at 12 weeks
The serum concentration of LIF is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 9.31 pg/ml; Standard curve range, 68.1 - 16,550 pg/ml, R&D systems).
Changes from baseline serum levels of LIF at 12 weeks
Changes of serum levels of myokines (6).
기간: Changes from baseline serum levels of follistatin at 12 weeks
The serum concentration of follistatin is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 133 pg/ml; Standard curve range, 2.6 - 650 ng/ml, R&D systems).
Changes from baseline serum levels of follistatin at 12 weeks
Changes of serum levels of myokines (7).
기간: Changes from baseline serum levels of fractalkine at 12 weeks
The serum concentration of fractalkine is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 64.8 pg/ml; Standard curve range, 1.3 - 325.8 ng/ml, R&D systems).
Changes from baseline serum levels of fractalkine at 12 weeks
Changes of serum levels of myokines (8).
기간: Changes from baseline serum levels of FGF-21 at 12 weeks
The serum concentration of FGF-21 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 27 pg/ml; Standard curve range, 623 - 151,330 pg/ml, R&D systems).
Changes from baseline serum levels of FGF-21 at 12 weeks
Changes of serum levels of myokines (9).
기간: Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks
The serum concentration of SPARC (osteonectin) is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 97.9 pg/ml; Standard curve range, 3.4 - 829.9 ng/ml, R&D systems).
Changes from baseline serum levels of SPARC (osteonectin) at 12 weeks
Changes of serum levels of myokines (10).
기간: Changes from baseline serum levels of irisin at 12 weeks
The serum concentration of irisin is measured by commercial enzyme-linked immunosorbent assay kits (Minimal detectable density, 1.29 ng/ml; Standard curve range, 0.1 - 1,000 ng/ml, Phoenix Pharmaceuticals).
Changes from baseline serum levels of irisin at 12 weeks
Changes of serum levels of inflammatory-related cytokines (1)
기간: Changes from baseline serum levels of IL-1 beta at 12 weeks
The serum concentration of IL-1 beta is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 0.8 pg/ml; Standard curve range, 17.8 - 4,320 pg/ml, R&D systems).
Changes from baseline serum levels of IL-1 beta at 12 weeks
Changes of serum levels of inflammatory-related cytokines (2)
기간: Changes from baseline serum levels of IL-10 at 12 weeks
The serum concentration of IL-10 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 1.6 pg/ml; Standard curve range, 13.7 - 3,340 pg/ml, R&D systems).
Changes from baseline serum levels of IL-10 at 12 weeks
Changes of serum levels of inflammatory-related cytokines (3)
기간: Changes from baseline serum levels of IL-11 at 12 weeks
The serum concentration of IL-11 is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 24.7 pg/ml; Standard curve range, 0.5 - 125.4 ng/ml, R&D systems).
Changes from baseline serum levels of IL-11 at 12 weeks
Changes of serum levels of inflammatory-related cytokines (4)
기간: Changes from baseline serum levels of TNF-alpha at 12 weeks
The serum concentration of TNF-alpha is measured using commercial luminex multiplexed cytokine assay panels (Minimal detectable density, 1.2 pg/ml; Standard curve range, 14 - 3,410 pg/ml, R&D systems).
Changes from baseline serum levels of TNF-alpha at 12 weeks
Changes of bone mineral density
기간: Changes from baseline bone mineral density at 12 weeks
Bone mineral density is expressed as T-score, which is measured by a compact ultrasonometer at calcaneus (Achilles Express, GE LUNAR Corp., Madison, WI)
Changes from baseline bone mineral density at 12 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Wonju Severance Christian Hospital

수사관

  • 연구 의자: In Deok Kong, Professor, Yonsei University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2014년 5월 1일

기본 완료 (예상)

2023년 3월 1일

연구 완료 (예상)

2023년 12월 1일

연구 등록 날짜

최초 제출

2016년 8월 21일

QC 기준을 충족하는 최초 제출

2016년 9월 4일

처음 게시됨 (추정)

2016년 9월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 4월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 4월 6일

마지막으로 확인됨

2021년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • LOHAS-BCS

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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위치

구독하다