A Study to Evaluate the Efficacy and Safety of Orally Administered Extract of Orthosiphon Stamineus (NuvastaticTM-C5OSEW5050ESA) in Patient With Breast Cancer Undergoing Chemotherapy

Phase III Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Breast Cancer Patients Undergoing Chemotherapy

The goal of this clinical trial is to determine whether Nuvastatic™ can reduce cancer-related fatigue and improve quality of life in adult female patients with breast cancer undergoing standard chemotherapy.

The main questions it aims to answer are:

Does Nuvastatic™ reduce cancer-related fatigue as measured by change in the Brief Fatigue Inventory (BFI) from baseline to end of treatment? Does Nuvastatic™ improve quality of life, safety outcomes, and clinical parameters compared with placebo during chemotherapy?

Researchers will compare patients receiving Nuvastatic™ plus standard chemotherapy with patients receiving placebo plus standard chemotherapy to see if Nuvastatic™ leads to greater reductions in fatigue, improved quality of life, and acceptable safety while undergoing treatment.

Participants will:

• Receive Nuvastatic™ or matching placebo as a 1000 mg effervescent sachet taken three times daily after meals for three chemotherapy cycles
• Continue their standard-of-care chemotherapy as prescribed by their treating physician
• Complete fatigue and quality-of-life questionnaires (BFI, SF-36, EORTC QLQ-C30)
• Undergo routine clinical assessments, laboratory tests, ECGs, and safety monitoring
• Undergo CT imaging for tumor response assessment according to RECIST 1.1

Inclusion Criteria:

1. Female Patients aged ≥ 18 years and ≤65 years who are willing to voluntarily provide consent for participation in the study.
2. Confirm diagnosis of Breast cancer as per the available Report.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
4. The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
5. Life expectancy ≥ 6 months, as per Investigator's judgment
6. Patients with co-morbidities or medical conditions including Type 2 DM, hypertension and are deem stable by the investigator can be included in the study
7. At screening patient with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included.

Exclusion Criteria:

1. 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 judgement.
2. Patient who have stage IV Disease
3. Female patients who are pregnant or breast-feeding.
4. Patients with known hepatitis C virus, hepatitis B virus, HIV infection.
5. 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.
6. Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. '
7. Patients with planned therapy or treatment with another investigational agent.
8. 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.