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De klinische studie NCT04589468 voor Borstkanker, prostaatkanker, Colorectale kanker, Stadium I borstkanker, Stadium II borstkanker, Stadium III Borstkanker, Stadium I prostaatkanker, Stadium II prostaatkanker, Stadium III prostaatkanker, Stadium I colorectale kanker, Stadium II colorectale kanker, Stadium III colorectale kanker is actief, niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Memorial Sloan Kettering KankercentrumResearching the Effect of Exercise on Cancer
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De klinische studie NCT04589468 is een interventioneel studie bij Borstkanker, prostaatkanker, Colorectale kanker, Stadium I borstkanker, Stadium II borstkanker, Stadium III Borstkanker, Stadium I prostaatkanker, Stadium II prostaatkanker, Stadium III prostaatkanker, Stadium I colorectale kanker, Stadium II colorectale kanker, Stadium III colorectale kanker met de status actief, niet rekruterend. Het doel is om 33 deelnemers te includeren vanaf 2 oktober 2020. De studie wordt geleid door Memorial Sloan Kettering Kankercentrum en de voltooiing is gepland op 2 oktober 2026. Laatste update op ClinicalTrials.gov: 5 november 2025.
Beknopte samenvatting
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.
Officiële titel
Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
Aandoeningen
BorstkankerprostaatkankerColorectale kankerStadium I borstkankerStadium II borstkankerStadium III BorstkankerStadium I prostaatkankerStadium II prostaatkankerStadium III prostaatkankerStadium I colorectale kankerStadium II colorectale kankerStadium III colorectale kankerAndere studie-ID's
- 20-378
NCT-ID
Startdatum (Werkelijk)
2020-10-02
Laatste update geplaatst
2025-11-05
Verwachte einddatum
2026-10-02
Inschrijving (Geschat)
33
Studietype
Interventioneel
FASE
N.v.t.
Status
Actief, niet rekruterend
Trefwoorden
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
Primaire doel
Preventie
Toewijzing
Niet-gerandomiseerd
Interventiemodel
Sequentieel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelDose-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. | Oefening 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. |
ExperimenteelDose 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. | Oefening 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. |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
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 Kankercentrum737 actieve klinische studies om te verkennenGeen contactgegevens beschikbaar
8 Studielocaties in 1 landen
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