Thalidomide for Preventing Radiation-Induced Dermatitis in Breast Cancer Patients (THAL-RID-BC)
Thalidomide for Prevention of Radiation-Induced Dermatitis in Breast Cancer Patients After Breast-Conserving Surgery Receiving Radiotherapy: A Randomized Controlled Study
To evaluate the efficacy and safety of oral thalidomide for the prevention of radiation-induced dermatitis (RID) in breast-conserving surgery patients receiving intensity-modulated whole-breast radiotherapy. This is a single-center randomized controlled trial. Female breast cancer patients aged >18 and <70 years after breast-conserving surgery scheduled for whole-breast intensity-modulated radiotherapy will be enrolled. Subjects will be randomized at a 1:1 ratio to the intervention group (thalidomide 75 mg orally every bedtime plus standard skin care) or the control group (standard skin care alone). The observation window is defined as from the start of first radiotherapy to 42 days after completion of last radiotherapy. RID will be assessed weekly according to CTCAE v5.0, and the maximum grade within the observation window will be recorded for each subject. The primary endpoint is the incidence of grade ≥2 RID within the observation window. Secondary endpoints include incidence of grade ≥3 RID, time-to-first-onset of grade ≥2 RID, RID-related symptoms (burning, pruritus, pulling pain, tenderness), quality-of-life measured by EORTC QLQ-C30 / QLQ-BR23. Treatment-emergent adverse events will be documented using CTCAE v5.0, with special attention to thalidomide-related toxicities such as somnolence, peripheral sensory neuropathy and thromboembolism. A total of 68 participants are planned for enrolment.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Zhendong Yang, MD
- Número de teléfono: +86 7715356509
- Correo electrónico: yangzhendong@stu.gxmu.edu.cn
Ubicaciones de estudio
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Guangxi
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Nanning, Guangxi, Porcelana, 530011
- Reclutamiento
- The First Affiliated Hospital of Guangxi Medical University
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Female patients with histopathologically confirmed breast cancer after breast-conserving surgery, no distant metastasis, scheduled for intensity-modulated radiotherapy (IMRT).
- Age greater than 18 years and less than 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate laboratory examinations obtained within 14 days before enrolment (without prior blood transfusion): white blood cell (WBC) ≥3.0 × 10⁹/L, absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet (PLT) ≥100 × 10⁹/L, hemoglobin (Hb) ≥90 g/L; total bilirubin (TBIL) ≤2.0 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5 × ULN, or creatinine clearance ≥60 mL/min calculated by the Cockcroft-Gault formula.
- No prior history of breast or chest-wall radiotherapy.
- For women of child-bearing potential: negative serum or urine pregnancy test within 72 hours prior to enrolment; fully informed of the teratogenic risk of thalidomide and agree to use dual effective contraception throughout study-drug administration and for 4 weeks after drug discontinuation; subjects refusing contraception are excluded. Post-menopausal women (amenorrhea for ≥12 consecutive months) do not require pregnancy testing.
- Fully informed of the study content, voluntarily provide written informed consent, and are able to complete radiotherapy, study medication, scheduled assessments and follow-up visits.
- For patients who received prior adjuvant chemotherapy: at least a 2-week interval between completion of chemotherapy and commencement of radiotherapy.
Exclusion Criteria:
- History of other malignant tumours (except cured in situ carcinoma).
- Psychiatric disorders or severe cognitive impairment that prevent subjects from completing questionnaires and assessments.
- Pregnant or lactating women.
- Poorly controlled diabetes mellitus (HbA1c > 7.5%); patients with well-controlled diabetes are eligible.
- Active autoimmune or rheumatic diseases (systemic lupus erythematosus, dermatomyositis, scleroderma, etc.); subjects with stable mild disease without systemic medication may be considered.
- Pre-existing or past history of peripheral neuropathy (numbness, tingling, paraesthesia); prior exposure to thalidomide, lenalidomide, pomalidomide; concomitant use of medications known to induce peripheral neurotoxicity.
- Past history of venous thromboembolism (VTE); hereditary thrombophilia; ongoing oestrogen-containing therapy.
- Severe cardiovascular and cerebrovascular diseases: myocardial infarction, unstable angina or stroke within the past 6 months; left ventricular ejection fraction (LVEF) < 50%.
- Pre-existing active eczema, psoriasis, chronic dermatitis, unhealed wounds or extensive scarring within the radiation field.
- Contraindications to radiotherapy.
- Known hypersensitivity to thalidomide or excipients of the preparation.
- Planned use of any additional oral or topical agents or dressings for prevention or treatment of radiation-induced dermatitis during study participation.
- Other conditions judged by the investigator making the subject unsuitable for this clinical trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: Thalidomide plus Standard Care Group
Patients receive oral thalidomide together with standard supportive care concurrently with breast cancer radiotherapy for the prevention of radiation dermatitis. |
Patients receive thalidomide 75 mg orally once every night at bedtime, starting from the first fraction of radiotherapy until completion of the last fraction of radiotherapy. All patients receive uniform standard skin care education and guidance for radiation field skin: wear loose fitting 100% cotton tops; avoid direct sunlight exposure to irradiated skin; keep irradiated skin dry, clean and well ventilated; avoid friction and scratching. |
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Comparador activo: Standard Care Control Group
Patients receive only standard supportive care during breast cancer radiotherapy, without thalidomide. |
All patients receive uniform standard skin care education and guidance for radiation field skin: wear loose fitting 100% cotton tops; avoid direct sunlight exposure to irradiated skin; keep irradiated skin dry, clean and well ventilated; avoid friction and scratching. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of grade ≥2 acute radiation dermatitis
Periodo de tiempo: From first radiation fraction to 42 days after completion of radiotherapy
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Proportion of participants developing grade 2 or worse acute radiation dermatitis, assessed using CTCAE Version 5.0. |
From first radiation fraction to 42 days after completion of radiotherapy
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient-reported burning symptom of radiation-induced dermatitis
Periodo de tiempo: Baseline to 42 days after completion of radiotherapy
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Patient-reported severity of burning measured by a numeric rating scale (0-5; 0 = no symptom, 5 = worst imaginable symptom). Assessments are performed at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 42 days after completion of radiotherapy. |
Baseline to 42 days after completion of radiotherapy
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Patient-reported pruritus symptom of radiation-induced dermatitis
Periodo de tiempo: Baseline to 42 days after completion of radiotherapy
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Patient-reported severity of pruritus measured by a numeric rating scale (0-5; 0 = no symptom, 5 = worst imaginable symptom). Assessments are performed at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 42 days after completion of radiotherapy. |
Baseline to 42 days after completion of radiotherapy
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Patient-reported pulling pain symptom of radiation-induced dermatitis
Periodo de tiempo: Baseline to 42 days after completion of radiotherapy
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Patient-reported severity of pulling pain measured by a numeric rating scale (0-5; 0 = no symptom, 5 = worst imaginable symptom). Assessments are performed at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 42 days after completion of radiotherapy. |
Baseline to 42 days after completion of radiotherapy
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Patient-reported tenderness symptom of radiation-induced dermatitis
Periodo de tiempo: Baseline to 42 days after completion of radiotherapy
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Patient-reported severity of tenderness measured by a numeric rating scale (0-5; 0 = no symptom, 5 = worst imaginable symptom). Assessments are performed at baseline, weekly during radiotherapy, at the end of radiotherapy, and at 42 days after completion of radiotherapy. |
Baseline to 42 days after completion of radiotherapy
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Health-related quality of life
Periodo de tiempo: Baseline to 6 months after completion of radiotherapy
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Health-related quality of life will be assessed using the EORTC QLQ-C30 questionnaires. Assessments are performed at baseline (before the first radiotherapy fraction), 42 days, 3 months and 6 months after completion of radiotherapy. A mixed-effects model will be used to analyse longitudinal changes in subscale scores. Changes from baseline in each subscale at 42 days, 3 months and 6 months after radiotherapy will be calculated and compared between groups. |
Baseline to 6 months after completion of radiotherapy
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Health-related quality of life QLQ-BR23
Periodo de tiempo: Baseline to 6 months after completion of radiotherapy
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Health-related quality of life will be assessed using the QLQ-BR23 questionnaires. Assessments are performed at baseline (before the first radiotherapy fraction), 42 days, 3 months and 6 months after completion of radiotherapy. A mixed-effects model will be used to analyse longitudinal changes in subscale scores. Changes from baseline in each subscale at 42 days, 3 months and 6 months after radiotherapy will be calculated and compared between groups. |
Baseline to 6 months after completion of radiotherapy
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Adverse events and serious adverse events
Periodo de tiempo: From enrolment to at least 3 months after the last dose of study drug
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Adverse events are graded according to CTCAE Version 5.0. Special attention will be paid to thalidomide-related toxicities, including somnolence, peripheral sensory neuropathy and venous thromboembolism. |
From enrolment to at least 3 months after the last dose of study drug
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Zhendong Yang, First Affiliated Hospital of Guangxi Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Heridas y Lesiones
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Lesiones por radiación
- Dermatitis
- Enfermedades de la piel y del tejido conectivo
- Neoplasias de mama
- Radiodermatitis
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Ácidos carboxílicos
- Piperidinas
- Ftalimidas
- Ácidos ftálicos
- Ácidos, carbocíclicos
- Piperidonas
- Isoindoles
- Talidomida
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2024-S908-01
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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