Actively Recruiting
Phase 3 Trial of Nuvastatic to Reduce Fatigue in Adults with Stage IV Colon Cancer Undergoing First-Line Chemotherapy
Led by Natureceuticals Sdn Bhd · Updated on 2026-06-25
180
Participants Needed
6
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether Nuvastatic can reduce cancer-related fatigue in adults with stage IV colon cancer who are undergoing first-line chemotherapy. The study aims to determine if Nuvastatic improves fatigue scores compared to placebo and if it is safe and well tolerated in this patient group. This phase 3 trial focuses on supportive care to improve quality of life during chemotherapy. Participants will be randomly assigned to receive either Nuvastatic or a placebo, both given as 1000mg sachets taken three times daily. Treatment with these sachets will continue for three cycles of 20 days each, totaling approximately 60 days, alongside their standard chemotherapy regimen. Blood samples for biomarkers such as CEA and CA-125 will be collected at screening and at the end of treatment. Throughout the study, participants will complete patient diaries and fatigue assessments to track changes in cancer-related fatigue. Researchers will monitor fatigue levels from screening up to 12 weeks and assess overall quality of life and functional improvements at baseline and study end. Safety and tolerability of Nuvastatic will also be observed during this period.
CONDITIONS
Brief Title
Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Stage IV Colon Cancer Patients Undergoing First-Line Chemotherapy
Research Team
A
Aman Shah Abdul Majid, MBChB, DPhil
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