Clinical Trial

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300mg Capsule in Reducing Cancer-Tumor in Patients With Metastatic Colorectal Cancer Receiving Standard Chemotherapy.

Study acronym: NuvastaticTM
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to evaluate whether Nuvastatic 300 capsule 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 capsule significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic 300 capsule safe and well tolerated in this patient population? Researchers will compare Nuvastatic 300 capsule vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile. Participants will: Receive Nuvastatic 300 capsule or placebo capsules (3 times per day) for 6 cycles of 20 days each (total \~120 treatment days). Continue their standard first-line chemotherapy regimen. Provide blood samples assessment at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.
Trial Details
NCT Number NCT07669454
Lead Sponsor Natureceuticals Sdn Bhd
Conditions Fatigue Related to Cancer Treatment, Colon Cancer
Enrollment 250 participants
Start Date 2025-10-01
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-25