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임상시험 NCT05468034은(는) 유방암, Indolent Metastatic Breast Cancer에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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인디애나 대학교Exercise in Metastatic Breast Cancer: EMBody
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '시험 설명하기'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT05468034은(는) 유방암, Indolent Metastatic Breast Cancer에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2023년 4월 26일에 시작되어 100명의 참여자를 모집하고 있습니다. 인디애나 대학교이(가) 진행하며, 2027년 12월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 5월 1일에 갱신되었습니다.
간단한 개요
The purpose of this study is to study exercise in a novel population with indolent MBC (no progression on current therapy in prior 12 months and not receiving cytotoxic chemotherapy). The study team hypothesizes that delivering virtual, supervised, progressive intensity aerobic and resistance training exercise for 16 weeks in this population will significantly improve 1) cardiorespiratory fitness, functional status, and sarcopenia (low muscle mass), all established predictors of survival, and 2) patient- reported outcomes.
상세한 설명
This is a randomized, two arm, single-center study designed to compare the effect of exercise versus usual care control on the clinical parameter of cardiorespiratory fitness, in patients with metastatic breast cancer with indolent disease biology over a 16-week period. This study will be enrolling up to 100 participants. Participants will be randomized 1:1 in blocks of 4 to the exercise intervention or usual care, stratified by frailty yes/no defined by baseline SPPB score ≤ 8 or > 8.
Primary Objective To compare the effect of a 16-week multimodality, virtually delivered exercise intervention on cardiorespiratory fitness measured by a modified Bruce ramp protocol treadmill test to usual care, in patients with indolent metastatic breast cancer.
Secondary Objectives
- To compare the effect of exercise versus usual care on objective physical function measured by the short physical performance battery (SBBP)
- To compare the effect of exercise versus usual care on subjective physical functioning measured by PROMIS-29 questionnaire
- To compare the effect of exercise versus usual care on body composition, measured by visceral adiposity, lean muscle mass, and muscle density on CT scans obtained as standard of care using SliceOmatic software
- To compare the effect of exercise versus usual care on objective physical activity measured by accelerometer wear
- To compare the effect of exercise versus usual care on patient reported outcomes, including fatigue (BFI) and health related quality of life (PROMIS-29)
- To determine the fidelity of the exercise intervention, measured by changes in measures of constructs of habit and intention administered by questionnaire
- To describe patient uptake and adherence with the intervention, measured by proportion of approached patients who consent to the study, and proportion of assigned training sessions attended by patients randomized to the exercise arm.
공식 제목
Exercise in Metastatic Breast Cancer: EMBody
질환/상태
유방암Indolent Metastatic Breast Cancer출판물
이 임상 시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- CTO-IUSCCC-0781
NCT 번호
실제 연구 시작일
2023-04-26
최신 업데이트 게시
2025-05-01
예상 연구 완료일
2027-12
계획된 등록 인원
100
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
breast cancer
indolent metastatic breast cancer
exercise
indolent metastatic breast cancer
exercise
주요 목적
지지요법
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (공개라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Exercise Intervention Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes. | 운동 중재 Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes. |
비개입Usual Care Participants randomized to usual care (UC) will receive care per their treatment team. UC participants are encouraged to exercise but will not be provided components of the intervention. Participants in the UC arm will be given usual care handouts at baseline from the American College of Sports Medicine. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change in cardiorespiratory fitness | Measured by minutes on the treadmill | baseline, 16 weeks |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
physical performance battery | total score on short physical performance battery | baseline, 8, and 16 weeks |
Mean quality of life, as measured by the Patient-Reported Outcomes Measurement Information System-29 | Likert-scaled questionnaire, with response scores ranging from 1 to 5. Scores alternate from 1 or 5 being the lowest value. | baseline, 8, and 16 weeks |
muscle mass | measured by mg/kg2 on HU on PET/CT scans | baseline, and 16 weeks |
muscle density | measured by mg/kg2 on HU on CT scans | baseline, and 16 weeks |
adipose mass | measured by mg/kg2 on HU on CT scans | baseline, and 16 weeks |
Change in physical activity minutes | measured by accelerometer data | baseline to post 16-week intervention |
Change in steps per day | measured by accelerometer data | baseline to post 16-week intervention |
Mean fatigue score as measured by the basic fatigue inventory (BFI) | Likert-scaled questionnaire, with response scores ranging from 0 to 10, with 10 being the worse response. | baseline, and16-weeks |
Change intention and habits, as measured by the Behavioral Theory Scales | Likert-scaled questionnaire, measured with a 5-point Likert scale with response options ranging from "strongly disagree" to "strongly agree." Total scores are summed in the range of 40 to 200, with a higher score indicating stronger motivation that could predict exercise behavior. | baseline, and 16-weeks |
Uptake of the study | the proportion of total patients approached, screened, and ultimately completing the baseline assessments | date open to accrual until closed to accrual, up to 2 years |
Adherence with the intervention defined | the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm | baseline to post 16-week intervention |
change in patient-reported functional limitations, as measured by a functional limitations scale | mean score of 5 question scale, where participants responses are either scored 0 or 1, with "some difficulty" a 1 and "no difficulty" as a 0. | baseline, and16-weeks |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
Age ≥ 18 years
Diagnosis of metastatic breast cancer
No progression of disease in the 12 months prior to screening per the treating investigator
- If participant has changed treatments in the prior 12 months for reasons other than progressive disease, they remain eligible
- Participants on no treatment or "no evidence of disease" but still with a diagnosis of metastatic breast cancer are eligible
ECOG performance status of 0-2
Ability to walk on a treadmill without assistive device.
Informed consent and authorization of the release of health information must be obtained according to institutional guidelines
Currently not meeting physical activity guidelines (defined as less than 150 minutes of moderate to vigorous exercise per week measured by the RPAQ questionnaire administered during screening)
Participants should have a cellular device compatible with iOS 15 or Android operating system 7.
Receiving cytotoxic chemotherapy at any point in the prior 12 months.
- Participants receiving endocrine therapy are eligible.
- Participants receiving targeted therapy or antibody therapy are eligible (examples including trastuzumab, pertuzumab, TDM-1, trastuzumab deruxtecan, sacituzumab govetecan, immunotherapy, CDK4/6 inhibitors, olaparib, alpelisib, etc.)
Any condition precluding supervised exercise participation. A letter from a physician supporting participation can supercede this eligibility criteria.
- NYHA class III or IV congestive heart failure
- Uncontrolled angina
- Myocardial infarction in the prior 12 months
- Orthopedic surgery in the previous 3 months or plans for orthopedic surgery during the study period
- Chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen
- Symptomatic peripheral vascular disease
- Or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator, including psychological illness
- History of fragility fracture
Active, untreated brain metastases
인디애나 대학교288개의 진행 중인 임상시험 탐색 가능연구 책임자
Tarah J Ballinger, MD, 책임연구자, Assistant Professor of Clinical Medicine, Indiana University
연구 대표 연락처
연락처: Malori Pojar, (317) 274-0899, [email protected]
연락처: Tarah Ballinger, MD, [email protected]
6 1개국에 임상시험 장소
Connecticut
Yale Cancer Center, New Haven, Connecticut, 06510, United States
Brenda Cartmel, PhD, 연락처, 203-737-5091, [email protected]
Tara Sanft, MD, 책임연구자
모집중
Indiana
IU Health West, Avon, Indiana, 46123, United States
Malori Pojar, 연락처, (317) 274-0899, [email protected]
Tarah Ballinger, MD, 책임연구자
모집중
IU Health Joe and Shelly Schwarz Cancer Center, Carmel, Indiana, 46032, United States
Malori Pojar, 연락처, (317) 274-0899, [email protected]
Tarah Ballinger, MD, 책임연구자
모집중
Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, 46202, United States
Malori Pojar, 연락처, (317) 274-0899, [email protected]
Tarah Ballinger, MD, 책임연구자
모집중
Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, 46202, United States
Malori Pojar, 연락처, (317) 274-0899, [email protected]
Tarah Ballinger, MD, 책임연구자
모집중
Massachusetts
Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Anna Tanasijevic, 연락처, 617.632.5584, [email protected]
Jennifer Ligibel, MD, 책임연구자
모집중