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El ensayo clínico NCT04589468 para Cáncer de mama, Cáncer de próstata, Cáncer colorrectal, Cáncer de mama en estadio I, Cáncer de mama en estadio II, Cáncer de Mama en Etapa III, Cáncer de próstata en estadio I, Cáncer de próstata en estadio II, Cáncer de próstata en estadio III, Cáncer colorrectal en estadio I, Cáncer colorrectal en estadio II, Cáncer colorrectal en estadio III está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Centro Nacional del Cáncer, JapónResearching the Effect of Exercise on Cancer
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT04589468 es un ensayo intervencionista para Cáncer de mama, Cáncer de próstata, Cáncer colorrectal, Cáncer de mama en estadio I, Cáncer de mama en estadio II, Cáncer de Mama en Etapa III, Cáncer de próstata en estadio I, Cáncer de próstata en estadio II, Cáncer de próstata en estadio III, Cáncer colorrectal en estadio I, Cáncer colorrectal en estadio II, Cáncer colorrectal en estadio III. Su estado actual es: activo, no reclutando. El ensayo se inició el 2 de octubre de 2020, con el objetivo de reclutar a 33 participantes. Dirigido por el Centro Nacional del Cáncer, Japón, se espera que finalice el 2 de octubre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 5 de noviembre de 2025.
Resumen
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.
Título oficial
Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
Condiciones médicas
Cáncer de mamaCáncer de próstataCáncer colorrectalCáncer de mama en estadio ICáncer de mama en estadio IICáncer de Mama en Etapa IIICáncer de próstata en estadio ICáncer de próstata en estadio IICáncer de próstata en estadio IIICáncer colorrectal en estadio ICáncer colorrectal en estadio IICáncer colorrectal en estadio IIIOtros ID del ensayo
- 20-378
Número del NCT
Inicio del ensayo (real)
2020-10-02
Última actualización
2025-11-05
Fecha de finalización (estimada)
2026-10-02
Inscripción (prevista)
33
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Activo, no reclutando
Palabras clave
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
Objetivo principal
Prevención
Método de asignación
No aleatorizado
Modelo de intervención
Asignación secuencial
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalDose-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. | Ejercicio 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. |
ExperimentalDose 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. | Ejercicio 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. |
Resultado primario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
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
Centro Nacional del Cáncer, Japón737 ensayos clínicos activos para explorarNo hay datos de contacto.
8 Sitios del ensayo en 1 países
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