Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer (NuvastaticTM)
23 de agosto de 2026 actualizado por: Natureceuticals Sdn Bhd
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300 mg Capsules in Reducing Chemotherapy-Induced Fatigue in Patients With Metastatic Triple-Negative Breast Cancer Receiving Standard Chemotherapy
The goal of this clinical trial is to evaluate whether Nuvastatic 300 mg capsules can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.
The main questions it aims to answer are:
- Does Nuvastatic 300 mg capsules significantly reduce cancer-related fatigue compared to placebo?
- Is Nuvastatic 300 mg capsules safe and well tolerated in this patient population?
Researchers will compare Nuvastatic 300 mg capsules vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.
Participants will:
- Receive Nuvastatic 300 mg capsules or placebo capsules (3 times per day) for 3 cycles of 20 days each (total ~60 treatment days).
- Continue their standard first-line chemotherapy regimen.
- Provide blood sample assessments at Screening and End of Treatment.
- Complete patient diaries and fatigue assessments as per protocol.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
250
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Aman Shah Abdul Majid, MBChB, DPhil
- Número de teléfono: +605-2490500
- Correo electrónico: amanharvard2020@outlook.com
Ubicaciones de estudio
-
-
Andhra Pradesh
-
Visakhapatnam, Andhra Pradesh, India, 530040
- Reclutamiento
- Omega Hospital Chinna Gadhili
-
Contacto:
- Dr Bella Ravi Shankar
-
-
Karnataka
-
Mysore, Karnataka, India, 570001
- Activo, no reclutando
- K R Hospital
-
-
Maharashtra
-
Jalgaon, Maharashtra, India, 425001
- Activo, no reclutando
- Jeevanjyoti Cancer Hospital
-
-
Mahrasta
-
Pune, Mahrasta, India, 411027
- Reclutamiento
- Sangavi Multispeciality Hospital Pvt. Ltd,
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Contacto:
- Dr. Nikhil Mallinath Shirsi
-
-
Tamil Nadu
-
Erode, Tamil Nadu, India, 638012
- Reclutamiento
- Erode Cancer Care Centre
-
Contacto:
- Dr. K. Velavan
-
-
Uttar Pradesh
-
Kanpur, Uttar Pradesh, India
- Activo, no reclutando
- International Oncology Cancer Tower 1
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Female patients aged ≥ 18 years and ≤ 65 years who are willing to voluntarily provide consent for participation in the study.
- Patients with confirmed triple negative metastatic breast cancer who are planned or scheduled to receive standard chemotherapy treatment for at least 4 to 6 cycles respectively.
- Patients must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guidelines.
- Patients must have at least one tumour lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.
- The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
- Life expectancy ≥ 6 months, as per the investigator's judgment.
- Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM) and hypertension who are deemed stable by the investigator can be included in the study.
- At screening, patients with stable fatigue, newly developed fatigue, or worsening fatigue scores as assessed by the Brief Fatigue Inventory (BFI) should be included.
Exclusion Criteria:
- Patients who have any untreated reversible medical condition which may cause fatigue (e.g. major metabolic or electrolyte disturbance, active infection, endocrine abnormalities) as per the investigator's clinical judgment.
- Patients with an inability to understand local language(s) for scales used for evaluations i.e. VAFS, BFI AND SF-36.
- Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.
- Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.
- Patients with known central nervous system (CNS) involvement.
- Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator, may affect the patient's safety or study participation and conduct.
- Female patients who are pregnant or breastfeeding.
- Patients with known hepatitis C virus, hepatitis B virus, HIV infection.
- Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the investigator.
- Patients with uncontrolled pain, who in the opinion of the investigator are not eligible for the study.
- Patients with known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.
- Patients with planned therapy or treatment with another investigational agent.
- Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an investigational agent, other than as specified by this protocol, during the study period.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
Cápsula de placebo
|
300mg capsule, (3 capsules X 3 times a day)
|
|
Experimental: Nuvastatic 300
Nuvastatic™ 300 capsule
|
300mg capsule, (3 capsules X 3 times a day)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Periodo de tiempo: From Screening to EOT (about 6 months)
|
The primary outcome measure is the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale.
|
From Screening to EOT (about 6 months)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Periodo de tiempo: From Screening to EOT (about 6 months)
|
The primary outcome measure is the intra-individual changes in the Visual Analogue Fatigue Scale (VAFS).
|
From Screening to EOT (about 6 months)
|
|
Overall QoL and functional improvement
Periodo de tiempo: at baseline and at end of the study (about 6 months)
|
The secondary outcome measure is the overall QoL improvement using the medical outcome scale Short Form-36 (SF-36).
|
at baseline and at end of the study (about 6 months)
|
|
Overall QoL and functional improvement
Periodo de tiempo: At baseline and at end of the study (about 6 months)
|
The secondary outcome measure is the overall QoL improvement using the ECOG scores that will be compared at baseline and at end of the study.
|
At baseline and at end of the study (about 6 months)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de octubre de 2025
Finalización primaria (Estimado)
30 de octubre de 2026
Finalización del estudio (Estimado)
30 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
7 de enero de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de junio de 2026
Publicado por primera vez (Actual)
25 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de agosto de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EBCT003
- NatureCeuticals Sdn Bhd (Otro número de subvención/financiamiento: NatureCeuticals Sdn Bhd)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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