Nuvastatic for Fatigue in Breast Cancer: A Phase III Trial

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled study compares Nuvastatic 300 mg capsules taken three times daily to placebo over about 60 treatment days (three 20-day cycles) in adult women with triple-negative metastatic breast cancer undergoing standard first-line chemotherapy. Participants will continue their chemotherapy while receiving the study drug or placebo and will have blood tests, diaries, and fatigue assessments to track responses and safety. The trial aims to determine if Nuvastatic can meaningfully lessen cancer-related fatigue and confirm tolerability in this population. Eligibility includes adults 18–65 with confirmed triple-negative disease, measurable lesions, adequate performance status, and stable blood counts. Locations span three hospitals in India, with Natureceuticals Sdn Bhd as lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Omega Hospital Chinna Gadhili
  Visakhapatnam, Andhra Pradesh, India Recruiting
• Sangavi Multispeciality Hospital Pvt. Ltd,
  Pune, Mahrasta, India Recruiting
• Erode Cancer Care Centre
  Erode, Tamil Nadu, India Recruiting
• K R Hospital
  Mysore, Karnataka, India Active not recruiting
• Jeevanjyoti Cancer Hospital
  Jalgaon, Maharashtra, India Active not recruiting
• International Oncology Cancer Tower 1
  Kanpur, Uttar Pradesh, India Active not recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.