Clinical Trial

Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Stage IV Colon Cancer Patients Undergoing First-Line Chemotherapy

Study acronym: NuvastaticTM
Recruiting Phase 3
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Summary
The goal of this clinical trial is to evaluate whether Nuvastatic can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy. The main questions it aims to answer are: Does Nuvastatic significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic safe and well tolerated in this patient population? Researchers will compare Nuvastatic vs placebo to see if Nuvastatic improves fatigue scores and maintains an acceptable safety profile. Participants will: Receive Nuvastatic or placebo sachets (3 times per day) for 3 cycles of 20 days each (total \~60 treatment days). Continue their standard first-line chemotherapy regimen. Provide blood samples for biomarkers (CEA, CA-125) at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.
Trial Details
NCT Number NCT07669519
Lead Sponsor Natureceuticals Sdn Bhd
Conditions Fatigue, Colon Cancer
Enrollment 180 participants
Start Date 2025-08-18
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-25