- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03091842
Exercise Intervention in Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer
Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
연구 개요
상태
정황
상세 설명
PRIMARY OBJECTIVES:
I. To determine the effects of a 4-month circuit, interval-based aerobic and resistance exercise (CARE) intervention on obesity-associated chronic inflammation.
SECONDARY OBJECTIVES:
I. To determine the effects of a 4-month CARE intervention on sarcopenic obesity.
TERTIARY OBJECTIVES:
I. To determine the effects of a 4-month CARE intervention on breast cancer prognosis and assess whether reductions in chronic inflammation are associated with breast cancer prognosis.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients undergo supervised CARE program over 50 minutes comprising of warm up over 5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
GROUP II: Patients undergo supervised traditional aerobic and resistance exercise (TARE) program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15 minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
GROUP III: Patients undergo home-based stretching program comprising of one set of 3-4 static stretching exercises held for 30 seconds 3 days per week for 16 weeks. Patients receive instructional digital video disc (DVD) and booklet of the flexibility exercises. Patients also complete a weekly activity log. After completion of the stretching program, patients may optionally undergo the CARE program as in group I.
After completion of study, patients are followed up at week 34, 8 and 12 months, and then every year for 8 years.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
California
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Los Angeles, California, 미국, 90033
- USC / Norris Comprehensive Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Postmenopausal (at time of diagnosis; including artificial menopause induced by previous hysterectomy) women newly diagnosed (stage I-III) breast cancer low grade disease positive for estrogen and progesterone receptors
- Are centrally obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) > 30 kg/m^2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat > 30% (estimated by bioelectrical impedance), and waist circumference > 35 inches (in)
- Have undergone a lumpectomy or mastectomy
- Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months
- Speak English or Spanish
- Is in breast cancer remission with no detectable disease present
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
- Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease
- Have not experienced a weight reduction >= 10% within past 6 months
- Currently participate in less than 60 minutes of structured exercise/week
- No planned reconstructive surgery with flap repair during trial and follow-up period
- May use adjuvant endocrine therapy if use will be continued for duration of study intervention
- Does not smoke (no smoking during previous 12 months)
- Willing to travel to the exercise facility at University of Southern California (USC)
Exclusion Criteria:
- Patients with metastatic disease
- Is not centrally obese
- Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Participates in more than 60 minutes of structured exercise/week
- Is planning reconstructive surgery with flap repair during trial and follow-up period
- Currently smokes
- Is unable to travel to the exercise facility at USC
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Group I (CARE program)
Patients undergo supervised CARE program over 50 minutes comprising of warm up over 5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
|
상관 연구
보조 연구
다른 이름들:
보조 연구
Undergo supervised CARE program
Undergo supervised TARE program
Undergo home-based stretching program
|
실험적: Group II (TARE program)
Patients undergo supervised TARE program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15 minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
|
상관 연구
보조 연구
다른 이름들:
Undergo supervised CARE program
Undergo supervised TARE program
Undergo home-based stretching program
|
활성 비교기: Group III (home-based stretching program)
Patients undergo home-based stretching program comprising of one set of 3-4 static stretching exercises held for 30 seconds 3 days per week for 16 weeks.
Patients receive instructional DVD and booklet of the flexibility exercises.
Patients also complete a weekly activity log.
After completion of the stretching program, patients may optionally undergo the CARE program as in group I.
|
상관 연구
보조 연구
다른 이름들:
보조 연구
Undergo supervised CARE program
Undergo supervised TARE program
Undergo home-based stretching program
Receive instructional DVD and booklet of the flexibility exercises
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Reduction of adipose tissue inflammation assessed by measuring M1 and M2 adipose tissue macrophages, crown-like structures, and adipose tissue secretion levels of inflammatory cytokines secreted
기간: Up to 16 weeks
|
Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes.
Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period.
Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month).
The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes.
|
Up to 16 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Distant DFS defined as events that are either lethal (death from any cause) or a direct threat to patient survival (distant recurrence or second primary invasive cancer)
기간: Up to 8 years
|
Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group.
Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group).
|
Up to 8 years
|
Overall survival
기간: From randomization to death from any cause, assessed up to 8 years
|
Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group.
Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group).
|
From randomization to death from any cause, assessed up to 8 years
|
Recurrence-free interval defined as events directly attributable to the original breast cancer including invasive ipsilateral breast tumor recurrence; local, regional or distant recurrence; and death from breast cancer
기간: Up to 8 years
|
A competing risks analysis will be conducted, with death modeled as a competing event, using the Fine-Gray proportional hazards model.
Analyses will be presented unadjusted, as well as adjusted for prognostic variables (age, estrogen receptor (ER)/HER2 status, tumor size, presence/number of positive nodes, and surgery (mastectomy vs. breast-sparing).
|
Up to 8 years
|
Sarcopenic obesity assessed using dual energy X-ray absorptiometry
기간: Up to 8 months
|
Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes.
Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period.
Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month).
The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes.
|
Up to 8 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Disease free survival (DFS)
기간: From randomization to documentation of disease recurrence or death from any cause, assessed up to 8 years
|
Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group.
Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group).
Ancillary analyses will assess associations of inflammation measures with DFS.
Results will be presented as hazard ratios, with 95% confidence intervals.
Unadjusted and adjusted survival curves will be presented by treatment group.
|
From randomization to documentation of disease recurrence or death from any cause, assessed up to 8 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Christina Dieli-Conwright, PhD, University of Southern California
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1B-16-11 (기타 식별자: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (미국 NIH 보조금/계약)
- NCI-2017-00070 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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