- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02878980
An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
PRIMARY OBJECTIVES:
I. To assess the feasibility of recruiting and enrolling newly diagnosed epithelial ovarian cancer patients who have undergone debulking surgery and will be starting platinum-based chemotherapy, to an exercise trial.
II. To evaluate adherence to the data collection and exercise trial protocol. It is necessary to determine the feasibility of collecting tablet-based questionnaire data and blood samples at multiple time points in one visit. It is also critical to determine whether the exercise intervention is feasible in this patient population.
SECONDARY OBJECTIVES:
I. To examine changes in DNA repair function before and after a single exercise session.
II. To examine changes in DNA repair function, body composition, quality of life, symptoms and patient satisfaction with care over the treatment time course.
III. To examine the effect of the exercise intervention on these measurements.
IV. To follow the patients an additional 12-months for clinical outcomes defined as death, cancer recurrence, or new primary cancer.
OUTLINE: Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.
After completion of study, patients are followed up for 12 months.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Duarte, California, Estados Unidos, 91010
- City of Hope Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Women who have been newly diagnosed with a first primary, epithelial ovarian cancer, have undergone surgical debulking and who will be treatment according to the Armstrong method
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
- Newly diagnosed, primary, epithelial ovarian cancer
- Have undergone surgical debulking
- Will be treated according to the Armstrong method
- Read and understand English
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Arm I (exercise intervention)
Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity.
Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.
|
Estudios correlativos
Estudios complementarios
Otros nombres:
Estudios complementarios
Undergo supervised 1-on-1 exercise sessions
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Adherence to the data collection and exercise trial protocol, defined as the number of sessions attended, questionnaires completed, and blood samples completed
Periodo de tiempo: 18 weeks
|
18 weeks
|
Feasibility of recruiting and enrolling patients to an exercise trial, defined as the number of people contacted, eligible consented and enrolled
Periodo de tiempo: 12 months
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in body composition
Periodo de tiempo: Baseline to 18 weeks
|
Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
|
Baseline to 18 weeks
|
Change in DNA repair function, assessed by host reactivation assays
Periodo de tiempo: Before single exercise session to after single exercise session, assessed up to 12 months
|
Will be analyzed using paired t-tests
|
Before single exercise session to after single exercise session, assessed up to 12 months
|
Change in DNA repair function, assessed by host reactivation assays
Periodo de tiempo: Baseline to 18 weeks
|
Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
|
Baseline to 18 weeks
|
Change in quality of life, assessed by questionnaires
Periodo de tiempo: Baseline to 18 weeks
|
Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
|
Baseline to 18 weeks
|
Change in symptoms, assessed by National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 version 2
Periodo de tiempo: Baseline to 18 weeks
|
Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
|
Baseline to 18 weeks
|
Change in treatment satisfaction, assessed by Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General
Periodo de tiempo: Baseline to 18 weeks
|
Will be analyzed using paired t-tests.
Data from women in course 1 will be compared to data in women in course 6.
|
Baseline to 18 weeks
|
Clinical outcome follow-up defined as death, cancer recurrence, or new primary cancer
Periodo de tiempo: Up to 12 months
|
Up to 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jessica Clague DeHart, PhD, City of Hope Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 15388 (Otro identificador: City of Hope Medical Center)
- NCI-2016-01183 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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