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治験 NCT04589468（対象：乳癌、前立腺癌、大腸がん、ステージI乳癌、ステージII乳がん、ステージIII乳癌、ステージI前立腺癌、ステージII前立腺がん、ステージIII前立腺癌、ステージI結腸直腸癌、ステージII大腸がん、ステージIII大腸癌）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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メモリアル・スローン・ケタリングがんセンターResearching the Effect of Exercise on Cancer
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04589468 は 介入研究 臨床試験 で、乳癌、前立腺癌、大腸がん、ステージI乳癌、ステージII乳がん、ステージIII乳癌、ステージI前立腺癌、ステージII前立腺がん、ステージIII前立腺癌、ステージI結腸直腸癌、ステージII大腸がん、ステージIII大腸癌 に関するものです。現在は 実施中／登録終了 で、2020年10月2日 から開始しています。33 名の参加者 の募集が計画されています。この治験は メモリアル・スローン・ケタリングがんセンター によって主催され、2026年10月2日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月5日 です。
概要
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.
公式タイトル
Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
疾患／病気
乳癌前立腺癌大腸がんステージI乳癌ステージII乳がんステージIII乳癌ステージI前立腺癌ステージII前立腺がんステージIII前立腺癌ステージI結腸直腸癌ステージII大腸がんステージIII大腸癌その他の研究識別子
- 20-378
NCT番号
開始日
2020-10-02
最終更新日
2025-11-05
終了予定日
2026-10-02
目標参加者数
33
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
Breast Cancer
Prostate Cancer
Colorectal Cancer
exercise
ctDNA
20-378
Memorial Sloan Kettering Cancer Center
Prostate Cancer
Colorectal Cancer
exercise
ctDNA
20-378
Memorial Sloan Kettering Cancer Center
主目的
予防
割付方法
非無作為化
介入モデル
逐次割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Dose-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. | 運動 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. |
実験的Dose 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. | 運動 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. |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
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
メモリアル・スローン・ケタリングがんセンター737 件のアクティブな治験を探索連絡先情報がありません。
8 1カ国の場所
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