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임상시험 NCT04589468은(는) 유방암, 전립선암, 대장암, 1기 유방암, II기 유방암, III기 유방암, 1기 전립선암, II기 전립선암, 3기 전립선암, 1기 대장암, II기 대장암, 3기 대장암에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Researching the Effect of Exercise on Cancer

진행중, 모집종료
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 NCT04589468은(는) 유방암, 전립선암, 대장암, 1기 유방암, II기 유방암, III기 유방암, 1기 전립선암, II기 전립선암, 3기 전립선암, 1기 대장암, II기 대장암, 3기 대장암에 대해 알아보는 중재연구입니다. 현재 상태는 진행중, 모집종료이며, 연구는 2020년 10월 2일에 시작되어 33명의 참여자를 모집하고 있습니다. 메모리얼 슬론 케터링 암센터이(가) 진행하며, 2026년 10월 2일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 11월 5일에 갱신되었습니다.
간단한 개요
Researchers think that exercise may be able to prevent cancer from coming back by lowering ctDNA levels. The purpose of this study is to explore how aerobic exercise (exercise that stimulates and strengthens the heart and lungs and improves the body's use of oxygen) can reduce the level of ctDNA found in the blood. During the study, the highest level of exercise that is practical, is safe, and has positive effects on the body that may prevent the return of cancer (including a decrease in ctDNA levels) will be found. Each level of exercise tested will be a certain number of minutes each week. Once the best level of exercise is found, it will be tested further in a new group of participants. All participants in this study will have been previously treated for breast, prostate, or colorectal cancer.
공식 제목

Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer

질환/상태
유방암전립선암대장암1기 유방암II기 유방암III기 유방암1기 전립선암II기 전립선암3기 전립선암1기 대장암II기 대장암3기 대장암
기타 연구 식별자
  • 20-378
NCT 번호
NCT04589468
실제 연구 시작일
2020-10-02
최신 업데이트 게시
2025-11-05
예상 연구 완료일
2026-10-02
계획된 등록 인원
33
연구종류
중재연구
단계/상
해당 없음
상태
진행중, 모집종료
키워드
Breast Cancer
Prostate Cancer
Colorectal Cancer
exercise
ctDNA
20-378
Memorial Sloan Kettering Cancer Center
주요 목적
예방
설계 할당
비랜덤화 배정
중재 모델
순차설계
맹검 (마스킹)
없음 (공개라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Dose-Finding/Escalation
Fifty (n=50) post-treatment patients with colorectal cancer or breast cancer, deemed high-risk of relapse. The study will use an adaptive continuous reassessment method (CRM) design to assign patients sequentially at trial entry to one of five escalated doses depending on the feasibility / tolerability of exercise therapy evaluated over the total treatment period. The primary objective of this phase 1a trial is to identify the RP2D of exercise therapy for further evaluation in the phase 1b trial.
운동
Exercise therapy in both phases will consist of individualized walking delivered 3 to 6 times weekly (over a 7-day period). Exercise treatment will be delivered for up to 18 months, or until progression of disease or withdrawal of consent, whichever comes first. The phase 1a trial will assess five doses of exercise therapy (i.e., 90, 150, 225, 300, and 375 mins/wk) delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule. The phase 1b trial will only test one dose of exercise therapy - the RP2D identified in the phase 1a trial.
실험적Dose Expansion
An independent cohort of 30 post-treatment patients with colorectal (n=15) or breast (n=15) cancer deemed high-risk of relapse. This cohort expansion trial will only evaluate the RP2D identified in the phase 1a trial. The primary objective of this phase 1b trial is to further evaluate the feasibility, safety, and biological activity of the RP2D.
운동
Exercise therapy in both phases will consist of individualized walking delivered 3 to 6 times weekly (over a 7-day period). Exercise treatment will be delivered for up to 18 months, or until progression of disease or withdrawal of consent, whichever comes first. The phase 1a trial will assess five doses of exercise therapy (i.e., 90, 150, 225, 300, and 375 mins/wk) delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule. The phase 1b trial will only test one dose of exercise therapy - the RP2D identified in the phase 1a trial.
주요결과변수
결과변수측정값 설명시간 범위
Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.
Using an adaptive phase 1 (non-randomized) design, non-exercising (i.e., \<60 mins/wk of moderate or vigorous exercise) post-treatment patients with primary breast, prostate, or colorectal cancer and detectable ctDNA (n=50) will be administered one of five escalating dose levels.
24 weeks
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체

  • Postsurgical diagnosis of patients with primary solid tumors at high-risk of relapse as defined by one of the following:

    ° High-risk primary solid tumor (e.g., colorectal, ovarian, non-small cell lung cancer) (colorectal cancer only for Phase 1a)

  • Stage 3 or

  • ctDNA positive

    ° High-risk breast cancer

  • Residual invasive disease in the breast or the lymph nodes following completion of neoadjuvant chemotherapy (NACT),

  • Estrogen receptor (ER), and/or progesterone receptor (PR) positive and HER2 negative,

  • CPS-EG score ≥ 3,

  • CPS-EG score ≥2 w ith ypN+, or

  • Recurrence score ≥ 25

  • No evidence of disease

  • Age ≥ 18

  • Interval of ≥ 1 month but ≤ 2 years following completion of all definitive adjuvant therapy

  • Non-exercising (i.e., < 30 minutes of moderate and < 20 mins of vigorous exercise/wk), as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry)

    ° If ≥ 30 minutes but less than 45 minutes of moderate exercise/week, or if ≥ 20 minutes but less than 30 minutes of vigorous exercise/week, patients may be eligible, at the discretion of the PI.

  • Cleared for exercise participation as per screening clearance via PAR-Q+

  • Willingness to comply with all study-related procedures

  • Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes
  • Any other current diagnosis of invasive cancer of any kind
  • Distant metastatic malignancy of any kind
  • Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Memorial Sloan Kettering Cancer Center logo메모리얼 슬론 케터링 암센터737개의 진행 중인 임상시험 탐색 가능
연락처 정보가 없습니다.
8 1개국에 임상시험 장소

California

Natera, Inc. (Data or Specimen Analysis Only), San Carlos, California, 94070, United States

New Jersey

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, 07645, United States

New York

Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, 11553, United States