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