High-Intensity Interval Training for Stage I-III Breast Cancer Patients
1 de abril de 2021 actualizado por: University of Southern California
High-Intensity Interval Training (HIT) for Breast Cancer Patients During Trastuzumab Use
This randomized pilot clinical trial studies the feasibility of high-intensity interval training in improving cardiovascular fitness in patients with stage I-III breast cancer undergoing chemotherapy with trastuzumab.
Trastuzumab helps patients live longer, but may cause side effects to the heart.
Aerobic exercise may help the heart function better, which may help protect it against side effects from trastuzumab.
Exercise may also help reduce fatigue and prevent cancer from coming back.
High-intensity interval training involves short bursts of higher intensity efforts with longer periods of recovery.
This may also allow patients who cannot exercise for a long period of time to still be physically active.
This trial studies whether patients can tolerate high-intensity interval training, and how well it works in improving fitness in patients with breast cancer receiving trastuzumab.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
PRIMARY OBJECTIVES:
I. To assess the feasibility (completion of > 80% exercise sessions) of utilizing high-intensity interval training (HIT).
II. To determine the effects of HIT on aerobic exercise adaptation when compared to delayed group.
III. To examine the effects of HIT on left ventricular function when compared to delayed group.
IV. To determine the effects of HIT on endothelial function, arterial stiffness, and vascular atherosclerosis when compared to delayed group.
OUTLINE: Participants are randomized to 1 of 2 groups.
ARM I: HIT (High-intensity Interval Training) group - Participants undergo HIT over 30 minutes, thrice weekly for 8 weeks.
ARM II: DEL (Delayed/usual care) group - Participants maintain their current sedentary activity level (< 60 minutes of total exercise per week) for 8 weeks. Participants document their weekly activity in an exercise log. Following completion of all study visits, participants are given the option to complete the HIT exercise program as in Arm I.
After completion of study, patients are followed up at weeks 9 and 17.
Tipo de estudio
Intervencionista
Inscripción (Actual)
31
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90033
- USC / Norris Comprehensive Cancer Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- English or Spanish speaking
- Diagnosed with early stage (I-III) breast cancer, without evidence of metastatic disease
- Planned (neo)adjuvant therapy with trastuzumab (Herceptin) and/or anthracycline-based chemotherapy
- Not currently pregnant or planning to become pregnant throughout the duration of cancer treatment
- Physician (oncologist) clearance to participate in exercise at moderate to high intensity
- Have read and signed study informed consent document (ICF)
- EXERCISE INCLUSION CRITERIA:
- Normal body temperature (=< 100 degrees F)
- Resting blood pressure and/or heart rate within normal limits
- Participants have not received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
Exclusion Criteria:
- Advanced stage (stage IV) or metastatic breast cancer diagnosis (screening for metastases with scans only needed if there is clinical suspicion for metastases)
- Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
- Uncontrolled hypertension or other uncontrolled chronic disease (e.g. diabetes mellitus, thyroid disease, pulmonary disease, etc.)
- Moderate to highly active level of physical activity (e.g. currently participating in >= 60 minutes of moderate aerobic activity weekly)
- Orthopedic or other restrictions or contraindications to high-intensity (cycling) exercise
- EXERCISE EXCLUSION CRITERIA:
- Presence of fever (>= 100 degrees F)
- Resting blood pressure and/or heart rate outside normal limits
- Participants have received intravenous or oral chemotherapy on the same day and prior to scheduled exercise session
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ARM I (HIT group)
Participants undergo HIT exercises over 30 minutes, thrice weekly for 8 weeks.
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Estudios correlativos
Estudios complementarios
Otros nombres:
Estudios complementarios
Undergo HIT
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Comparador activo: Arm II (Delayed group)
Participants maintain their current sedentary activity level (< 60 minutes of total exercise per week) for 8 weeks.
Participants document their weekly activity in an exercise log.
Following completion of all study visits, participants are given the option to complete the HIT program as in Arm I.
|
Estudios correlativos
Estudios complementarios
Otros nombres:
Estudios complementarios
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of utilizing HIT under clinical trial conditions, assessed using participant attendance rate
Periodo de tiempo: Up to 17 weeks
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The exercise program will be considered feasible if participants complete greater than 80% of exercise sessions.
Participant attendance rates will be used to establish compliance and will be used to provide a perspective on how and to what extent cancer patients will participate in an experimental exercise intervention and what variations in exercise intensities may be tolerated.
Feasibility will be assessed based on both program attendance as well as exercise time completed.
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Up to 17 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in aerobic exercise adaptation measured by the maximum volume of oxygen uptake (VO2peak) (ml/kg/min)
Periodo de tiempo: Baseline to up to week 17
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A mixed-effect regression model will be fit to compare the mean changes in VO2peak (ml/kg/min) between groups.
The effect of other covariates such as the menopausal age, severity of disease and the class of chemotherapy treatment and compliance rate on VO2peak (ml/kg/min) over time will also be examined.
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Baseline to up to week 17
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Change in left ventricular function
Periodo de tiempo: Baseline to up to week 17
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A mixed-effect model will be fit to compare the mean changes in left ventricular ejection fraction, left ventricular end-diastolic volume, left ventricular end-systolic volume, and peak filling time.
The effect of other covariates such as the menopausal age, severity of disease and the class of chemotherapy treatment and compliance rate on left ventricular function over time will also be examined.
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Baseline to up to week 17
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christina Dieli-Conwright, University of Southern California
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Lee K, Norris MK, Wang E, Dieli-Conwright CM. Effect of high-intensity interval training on patient-reported outcomes and physical function in women with breast cancer receiving anthracycline-based chemotherapy. Support Care Cancer. 2021 Nov;29(11):6863-6870. doi: 10.1007/s00520-021-06294-7. Epub 2021 May 20.
- Lee K, Kang I, Mack WJ, Mortimer J, Sattler F, Salem G, Dieli-Conwright CM. Feasibility of high intensity interval training in patients with breast Cancer undergoing anthracycline chemotherapy: a randomized pilot trial. BMC Cancer. 2019 Jul 3;19(1):653. doi: 10.1186/s12885-019-5887-7.
- Lee K, Kang I, Mack WJ, Mortimer J, Sattler F, Salem G, Lu J, Dieli-Conwright CM. Effects of high-intensity interval training on vascular endothelial function and vascular wall thickness in breast cancer patients receiving anthracycline-based chemotherapy: a randomized pilot study. Breast Cancer Res Treat. 2019 Sep;177(2):477-485. doi: 10.1007/s10549-019-05332-7. Epub 2019 Jun 24.
- Lee K, Kang I, Mortimer JE, Sattler F, Mack WJ, Fitzsimons LA, Salem G, Dieli-Conwright CM. Effects of high-intensity interval training on vascular function in breast cancer survivors undergoing anthracycline chemotherapy: design of a pilot study. BMJ Open. 2018 Jun 30;8(6):e022622. doi: 10.1136/bmjopen-2018-022622.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de septiembre de 2015
Finalización primaria (Actual)
15 de julio de 2019
Finalización del estudio (Actual)
15 de julio de 2019
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2015
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2015
Publicado por primera vez (Estimar)
27 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
1 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1B-14-5 (Otro identificador: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (Subvención/contrato del NIH de EE. UU.)
- NCI-2015-00579 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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