Clinical Trial

Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer

Study acronym: NuvastaticTM
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to evaluate whether Nuvastatic 300 mg capsules 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 300 mg capsules significantly reduce cancer-related fatigue compared to placebo? * Is Nuvastatic 300 mg capsules safe and well tolerated in this patient population? Researchers will compare Nuvastatic 300 mg capsules vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile. Participants will: * Receive Nuvastatic 300 mg capsules or placebo capsules (3 times per day) for 3 cycles of 20 days each (total \~60 treatment days). * Continue their standard first-line chemotherapy regimen. * Provide blood sample assessments at Screening and End of Treatment. * Complete patient diaries and fatigue assessments as per protocol.
Trial Details
NCT Number NCT07669467
Lead Sponsor Natureceuticals Sdn Bhd
Conditions Fatigue Related to Cancer Treatment, Breast Cancer
Enrollment 250 participants
Start Date 2025-10-01
Primary Completion 2026-10-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-25