OncoMatch/Clinical Trials/NCT07669454
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.
Is NCT07669454 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies Nuvastatic 300 for fatigue related to cancer treatment.
Treatment: Nuvastatic 300 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Disease stage
Required: Stage IV
Metastatic disease required
Patients must have at least one tumor lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Lab requirements
Blood counts
stable hemoglobin (≥ 9 g/dl) throughout the screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07669454 currently recruiting?
Yes, this trial is currently recruiting patients.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 65 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages