A Study of Different Skin Care Approaches to Prevent Skin Reactions in People With Breast Cancer Receiving Radiation Therapy After Mastectomy
OPTimal Intervention for the Prevention of Radiation Dermatitis During Breast Cancer Post-Mastectomy Radiotherapy (OPTIC): A Parallel, Three-Arm, Phase II Open-Label Randomized Trial
The purpose of this study is to find out which of three standard skin care approaches works best to prevent a skin reaction called radiation dermatitis (redness, irritation, or breakdown of the skin) in people receiving radiation therapy after mastectomy.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Atif Khan, MD
- Número de teléfono: 848-225-6334
- Correo electrónico: khana7@mskcc.org
Copia de seguridad de contactos de estudio
- Nombre: Isabelle Choi, MD
- Número de teléfono: 646-449-1997
- Correo electrónico: choij3@mskcc.org
Ubicaciones de estudio
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New Jersey
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Basking Ridge, New Jersey, Estados Unidos, 07920
- Reclutamiento
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
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Contacto:
- Isabelle Choi, MD
- Número de teléfono: 646-449-1997
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Middletown, New Jersey, Estados Unidos, 07748
- Reclutamiento
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
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Contacto:
- Isabelle Choi, MD
- Número de teléfono: 646-449-1997
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Montvale, New Jersey, Estados Unidos, 07645
- Reclutamiento
- Memorial Sloan Kettering Bergen (All Protocol Activities)
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Contacto:
- Isabelle Choi, MD
- Número de teléfono: 646-449-1997
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New York
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Commack, New York, Estados Unidos, 11725
- Reclutamiento
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )
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Contacto:
- Isabelle Choi, MD
- Número de teléfono: 646-449-1997
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Harrison, New York, Estados Unidos, 10604
- Reclutamiento
- Memorial Sloan Kettering Westchester (All Protocol Activities)
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Contacto:
- Isabelle Choi, MD
- Número de teléfono: 646-449-1997
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New York, New York, Estados Unidos, 10065
- Reclutamiento
- Memorial Sloan Kettering Cancer Center (All Protocol Activites)
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Contacto:
- Isabelle Choi, MD
- Número de teléfono: 646-449-1997
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Rockville Centre, New York, Estados Unidos, 11553
- Reclutamiento
- Memorial Sloan Kettering Nassau (All protocol activities)
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Contacto:
- Isabelle Choi, MD
- Número de teléfono: 646-449-1997
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients must have pathologically confirmed breast cancer.
- Patients will have an assigned sex of female at birth.
- Patients will have undergone mastectomy without breast reconstruction surgery or with immediate reconstruction using one or more of an expander, implant, or flap-based approach.
- Patients will have pathologic stage T1-3 N0-1 M0 disease with indication for comprehensive post-mastectomy radiotherapy to the ipsilateral chest wall and regional lymph node basins (axilla, SCV, IMN).
- Patient/LAR willing to sign and date consent form
- Age ≥ 18
- ECOG Performance Status of ≤ 2
Exclusion Criteria:
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Patients with indication for escalated skin dose (dermal invasion, skin involvement, positive surgical margin).
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Patients planned to receive a scar or chest wall, or other boost.
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Patients planned to receive post-mastectomy radiotherapy using a hypofractionated regimen (ie., >2.0 Gy per fraction).
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Patients who have a diagnosis of connective tissue disorder or collagen vascular disorder.
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Patients who have an active rash in the cervical or thoracic region.
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Patients taking systemic steroids >10 mg/day.
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Patients on active antimicrobial treatment at the time of study enrollment.
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Patients with a prior history of organ or bone marrow transplant.
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Patients who are pregnant or nursing
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Prior Treatment:
- Patients with prior history of radiotherapy to the neck, thorax or abdomen.
- Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for hypothyroidism requiring medication, which must have resolved to Grade ≤2, alopecia, and other toxicities considered clinically nonsignificant and/or stable on supportive therapy as determined by the investigator).
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Comorbid conditions:
o Active infection requiring parenteral antibiotic(s)
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Concomitant Medications:
o Concurrent systemic therapy during the course are not allowed, including cytotoxic chemotherapy, immunotherapy, and targeted therapy. Last dose of these agents must be delivered at least 2 weeks prior to start of radiotherapy and not to be restarted until at least 2 weeks following completion of radiotherapy. Endocrine therapy, pembrolizumab, Herceptin, Perjeta, and Kadcyla are allowed. Concurrent oral steroid medications are not allowed.
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Allergies:
- History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- 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 1: Mometasone furoate
An ARD prevention strategy that has demonstrated the ability to reduce significant radiation dermatitis during breast radiotherapy is the topical application of corticosteroid creams, including mometasone and betametasone |
Mometasone Furoate 1% Cream is a topical corticosteroid cream |
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Experimental: Arm 2: Mepitel Film
The use of barrier films such as Mepitel Film, Hydrofilm, and StrataXRT, has also been demonstrated to be effective in reducing the risk of clinically significant ARD. |
Mepitel Film is a transparent film with a contact layer with silicone adhesion. |
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Experimental: Arm 3: Bacterial decolonization
Bacterial decolonization (BD) is a intervention that has been studied as an ARD prevention measure. |
Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing Bacterial decolonization (BD) regimen involves a 5 day regimen of twice-daily intranasal mupirocin and chlorhexidine body cleansing |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of acute radiation dermatitis with most desquamation (ARD-MD)
Periodo de tiempo: 12 months
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To evaluate the rate of acute radiation dermatitis with moist desquamation (ARD-MD) using three acute radiation dermatitis (ARD) prevention strategies compared with historical rates using standard of care strategies in patients receiving post-mastectomy radiotherapy (PMRT). |
12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Isabelle Choi, MD, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-356
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Información sobre medicamentos y dispositivos, documentos del estudio
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