OncoMatch/Clinical Trials/NCT07669467

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

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300 mg Capsules in Reducing Chemotherapy-Induced Fatigue in Patients With Metastatic Triple-Negative Breast Cancer Receiving Standard Chemotherapy

Is NCT07669467 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 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.