Screening For BCRL In Targeted Therapy For Breast Cancer
Lymphedema · Lymphedema Arm · Lymphedema of Upper Arm · Lymphedema of Upper Limb · Lymphedema of the Hands · Edema · Edema Arm · Breast Cancer Lymphedema · Breast Cancer Metastatic · Breast Cancer Stage · Breast Cancer
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - 80 años
- Sexo admitido
- Femenino
- Voluntarios sanos
- No aceptados
- Participantes
- 261 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer.
A Perometer and Sozo devise will be used to measure volume changes
Leer la descripción completa
This study will compare patients' relative arm volume changes and symptoms data from before drug therapy throughout drug treatment and for up to six months after treatment has finished.
A Perometer and Sozo device will be used to measure volume changes
All participants will be accrued at Massachusetts General Hospital for a target accrual of 166 participants.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF/HCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.
- Subjects that will be eligible for the study include:
- Females between 18 and 80 years of age
- With a history of breast cancer
- 4 weeks or more post-surgery
- With or without edema
- Undergoing treatment with targeted therapy for early or metastatic disease.
Exclusion Criteria:
\- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).
Población del estudio
Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF/HCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Target Therapy Drug-Stand Care
Screening procedures confirm participation in the research study.
- Participants limb volume is measured prior to treatment start date.
- Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card.
- Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication
Device: Perometer · Device: SOZO device
Target Therapy-Early or Metastatic Breast Cancer
Screening procedures confirm participation in the research study.
- Participants limb volume is measured prior to treatment start date.
- Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card.
- Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication
Device: Perometer · Device: SOZO device
Perometer DEVICE
The perometer uses light sensors to calculate the length and volume of your arms
SOZO device DEVICE
The machine measures the amount of fluid on the arm(s)
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Proportion of participants with a greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery
Plazo: At least three months post surgery up to 5 years, assessed every 3 months
Greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery
Medidas secundarias
To assess the time course to lymphedema onset
Plazo: 5 Years
We will also attempt to look at any time course differences of lymphedema onset by plotting cumulative incidence curves of the study and control groups and comparing hazard rates after accounting for important covariates in a multivariate Cox proportional-hazards model.
To asses the correlation of different targeted therapies with lymphedema onset
Plazo: 5 Years
We will compare the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTOR, AKT).
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
Massachusetts General HospitalBoston, Massachusetts, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- Massachusetts General Hospital
- Inicio del estudio
- 13 dic 2018 Real
- Finalización primaria
- 30 sept 2027 Estimado
- Finalización del estudio
- 30 sept 2027 Estimado
- Primera publicación
- 3 dic 2021 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026