Nuvastatic ™
DrugGreenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet
NCT Number: NCT07669506
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
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Notify Me18 year–65 year
Female
Interventional
Phase 3
Department of Medical Oncology (In Charge - Oncology Unit), Govt. Medical College & Govt. General Hospital,, Srikakulam, Andhra Pradesh, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet
greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet
Time frame: At baseline until end of treatment at 12 weeks
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 and end of treatment at 12 weeks
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
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
To investigate whether urinary F2-isoprostane (F2-IsoP) excretion correlates with the severity of cancer-related fatigue (CRF) in patients undergoing chemotherapy
Natureceuticals Sdn Bhd
Industry
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
Acronym: NuvastaticTM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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