Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer (NuvastaticTM)
23 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
250
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Aman Shah Abdul Majid, MBChB, DPhil
- Numéro de téléphone: +605-2490500
- E-mail: amanharvard2020@outlook.com
Lieux d'étude
-
-
Andhra Pradesh
-
Visakhapatnam, Andhra Pradesh, Inde, 530040
- Recrutement
- Omega Hospital Chinna Gadhili
-
Contact:
- Dr Bella Ravi Shankar
-
-
Karnataka
-
Mysore, Karnataka, Inde, 570001
- Actif, ne recrute pas
- K R Hospital
-
-
Maharashtra
-
Jalgaon, Maharashtra, Inde, 425001
- Actif, ne recrute pas
- Jeevanjyoti Cancer Hospital
-
-
Mahrasta
-
Pune, Mahrasta, Inde, 411027
- Recrutement
- Sangavi Multispeciality Hospital Pvt. Ltd,
-
Contact:
- Dr. Nikhil Mallinath Shirsi
-
-
Tamil Nadu
-
Erode, Tamil Nadu, Inde, 638012
- Recrutement
- Erode Cancer Care Centre
-
Contact:
- Dr. K. Velavan
-
-
Uttar Pradesh
-
Kanpur, Uttar Pradesh, Inde
- Actif, ne recrute pas
- International Oncology Cancer Tower 1
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
Gélule placebo
|
300mg capsule, (3 capsules X 3 times a day)
|
|
Expérimental: Nuvastatic 300
Nuvastatic™ 300 capsule
|
300mg capsule, (3 capsules X 3 times a day)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 octobre 2025
Achèvement primaire (Estimé)
30 octobre 2026
Achèvement de l'étude (Estimé)
30 octobre 2026
Dates d'inscription aux études
Première soumission
7 janvier 2026
Première soumission répondant aux critères de contrôle qualité
22 juin 2026
Première publication (Réel)
25 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 août 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EBCT003
- NatureCeuticals Sdn Bhd (Autre subvention/numéro de financement: NatureCeuticals Sdn Bhd)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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