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El ensayo clínico NCT06483997 para Cáncer de mama en mujeres, Cáncer de ovario, Cáncer de trompa de Falopio, Carcinoma Peritoneal Primario, Cáncer endometrial, Cáncer Ginecológico 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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Diet, Hepcidin, and Chemotherapy RDI 100 Observacional Dietético

Activo, no reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06483997 es un estudio observacional para Cáncer de mama en mujeres, Cáncer de ovario, Cáncer de trompa de Falopio, Carcinoma Peritoneal Primario, Cáncer endometrial, Cáncer Ginecológico. Su estado actual es: activo, no reclutando. El estudio se inició el 16 de agosto de 2024, con el objetivo de reclutar a 100 participantes. Dirigido por la Universidad George Washington, se espera que finalice el 1 de julio de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 29 de enero de 2026.
Resumen
This prospective, observational cohort study will evaluate the extent of associations between self-reported pro- or anti- inflammatory dietary intake patterns for one month before induction chemotherapy for gynecological cancer or neo/adjuvant chemotherapy for breast cancer and baseline serum hepcidin concentrations. Associations between hepcidin concentration and relative dose intensity (RDI) of chemotherapy will al...Mostrar más
Descripción detallada
This is a prospective, observational cohort of 100 women receiving chemotherapy for breast or gynecological cancer at GW Cancer Center from July 1, 2024 - approximately September 2025. At study baseline (after diagnosis, but prior to starting chemotherapy), participants will complete a ~30-minute food frequency questionnaire (FFQ) and demographic/food security survey using a preprogrammed iPad in the clinic. The cli...Mostrar más
Título oficial

Associations Between Diet, Hepcidin, and Relative Dose Intensity Among Women Receiving Chemotherapy for Breast or Gynecological Cancer

Condiciones médicas
Cáncer de mama en mujeresCáncer de ovarioCáncer de trompa de FalopioCarcinoma Peritoneal PrimarioCáncer endometrialCáncer Ginecológico
Otros ID del estudio
  • NCR245680
Número del NCT
NCT06483997
Inicio del estudio (real)
2024-08-16
Última actualización
2026-01-29
Fecha de finalización (estimada)
2026-07
Inscripción (prevista)
100
Tipo de estudio
Observacional
Estado general
Activo, no reclutando
Palabras clave
nutrition
inflammation
anemia
toxicity
chemotoxicity
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Serum hepcidin concentration
ng/ml, continuous
pre-chemotherapy, single measure
Chemotherapy relative dose intensity
Calculated variable that represents the ratio of chemotherapy actually received during the duration of treatment to the planned chemotherapy dose during the planned duration
during chemotherapy (up to 6 months, depends on duration of chemotherapy regimen), represents repeated measures
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Hematologic toxicity
Incidence of CTCAE grade 3 or higher hematologic toxicity (anemia, neutropenia, thrombocytopenia)
at any point during chemotherapy or within 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Treatment delays
Delay of chemotherapy due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms
at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Treatment change or discontinuation
Change of chemotherapy regimen or discontinuation of treatment due to chemo-related adverse events, including hematologic toxicity, infection, hospitalization, or severe symptoms
at any point during chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Blood transfusion
Infusion of red blood cells, platelets, fresh frozen plasma, or other donated human blood products due to chemo-related hematologic toxicity
at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Hospitalizations
Unscheduled admission to a hospital or similar medical facility due to due to chemo-related adverse events, including hematologic toxicity, infection, or severe symptoms
at any point during chemotherapy or up to 30 days after completion of chemotherapy (up to 6 months, depends on length of chemotherapy regimen)
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
21 Years
Criterios de sexo
Mujer
  • Have been diagnosed with invasive breast cancer, OR
  • Have been diagnosed with epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, OR
  • Have been diagnosed with endometrial cancer
  • Are chemotherapy-naïve
  • Are scheduled to receive neoadjuvant chemotherapy (or adjuvant chemotherapy following lumpectomy for breast cancer patients) or neoadjuvant/induction chemotherapy for gynecological cancer at GW Cancer Center

  • Prior primary hematological condition that would cause abnormal blood counts (e.g. leukemia)
  • Pregnant at the time of potential enrollment
  • Receipt of erythropoietin-stimulating agents or blood transfusion in the 6 weeks prior to initial testing
  • Women who are cognitively unable to provide a diet history for the month prior to assessment.
George Washington University logoUniversidad George Washington
Parte responsable del estudio
Kimberly Robien, Investigador principal, Associate Professor, George Washington University
No hay datos de contacto.
1 Centros del estudio en 1 países

District of Columbia

George Washington University Cancer Center, Washington D.C., District of Columbia, 20052, United States