Clinical Trial: NCT07669506
A Study to Evaluate the Efficacy and Safety of Orally Administered Extract of Orthosiphon Stamineus (NuvastaticTM-C5OSEW5050ESA) in Patient With Breast Cancer Undergoing Chemotherapy
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Natureceuticals Sdn Bhd |
| Information Provided By: | Natureceuticals Sdn Bhd |
| Last Update Posted: | 2026-06-25 |
Study Overview
Brief Summary
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
Official Title
Conditions
Intervention / Treatment
- Drug: Nuvastatic ™
- Drug: Placebo
Other Study ID Numbers
- NUVA-BC-III-2025
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Natureceuticals Sdn Bhd |
| Information Provided By: | Natureceuticals Sdn Bhd |
| Last Update Posted: | 2026-06-25 |
Study Overview
Brief Summary
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
Official Title
Conditions
Intervention / Treatment
- Drug: Nuvastatic ™
- Drug: Placebo
Other Study ID Numbers
- NUVA-BC-III-2025