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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
180
Greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet
greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet
Department of Medical Oncology (In Charge - Oncology Unit), Govt. Medical College & Govt. General Hospital,
Srikakulam, Andhra Pradesh, India
Hanji Cancer Centre
Belagavi, Karnataka, India
K.R. Hospital, Mysore Medical College & Research Institute
Mysuru, Karnataka, India
Onco-Life Cancer Centre
Satara, Maharashtra, India
Onco-Life Cancer Centre, Pvt. Ltd (Talegaon General Hospital)
Talegaon Dābhāde, Maharashtra, India
Siddharth Gupta Memorial Cancer Hospital (A Unit of Acharya Vinoba Bhave Rural Hospital)
Wardha, Maharashtra, India
Avicenna Hospital
Lucknow, Uttar Pradesh, India
Change in Brief Fatigue Inventory (BFI) score
The primary outcome measure was the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale and Visual Analogue Fatigue Scale (VAFS).
Time frame: At baseline until end of treatment at 12 weeks
Overall QoL improvement using the medical outcome scale Short Form-36 (SF-36). ECOG scores were compared at baseline and at end of the study.
Secondary Outcome Measures are: Fatigue assessment using SF-36 Questionnaire from screening to EOT. Change in Global Health Status/QoL score as measured by EORTC QLQ-C30 from screening to EOT. Incidence of adverse events (AEs) graded according to CTCAE v5.0. Tumor response assessed by RECIST 1.1 criteria from baseline to EOT.
Time frame: At baseline and end of treatment at 12 weeks
Changes in biomarkers
Change in serum CEA (ng/mL) and CA15-3 (U/mL) levels from screening to EOT. Change in laboratory parameters from screening to EOT.
Time frame: At baseline and end of treatment at 12 weeks
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