Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer (NuvastaticTM)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Fatigue Related to Cancer Treatment
• Intervention / Treatment: Drug: Placebo; Drug: Nuvastatic 300

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Aman Shah Abdul Majid, MBChB, DPhil; Phone Number: +605-2490500; Email: amanharvard2020@outlook.com

Study Locations

• India
  • Andhra Pradesh
    • Visakhapatnam, Andhra Pradesh, India, 530040
      • Recruiting
      • Omega Hospital Chinna Gadhili
      • Contact: Dr Bella Ravi Shankar
  • Karnataka
    • Mysore, Karnataka, India, 570001
      • Active, not recruiting
      • K R Hospital
  • Maharashtra
    • Jalgaon, Maharashtra, India, 425001
      • Active, not recruiting
      • Jeevanjyoti Cancer Hospital
  • Mahrasta
    • Pune, Mahrasta, India, 411027
      • Recruiting
      • Sangavi Multispeciality Hospital Pvt. Ltd,
      • Contact: Dr. Nikhil Mallinath Shirsi
  • Tamil Nadu
    • Erode, Tamil Nadu, India, 638012
      • Recruiting
      • Erode Cancer Care Centre
      • Contact: Dr. K. Velavan
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India
      • Active, not recruiting
      • International Oncology Cancer Tower 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsule	Drug: Placebo; 300mg capsule, (3 capsules X 3 times a day)
Experimental: Nuvastatic 300; Nuvastatic™ 300 capsule	Drug: Nuvastatic 300; 300mg capsule, (3 capsules X 3 times a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.	The primary outcome measure is the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale.	From Screening to EOT (about 6 months)
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.	The primary outcome measure is the intra-individual changes in the Visual Analogue Fatigue Scale (VAFS).	From Screening to EOT (about 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall QoL and functional improvement	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	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)

Collaborators and Investigators

• Sponsor: Natureceuticals Sdn Bhd

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Cancer related fatigue; First-Line Chemotherapy; Nuvastatic; Randomized double blind placebo controlled trail
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: EBCT003; NatureCeuticals Sdn Bhd (Other Grant/Funding Number: NatureCeuticals Sdn Bhd)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No