OncRef

Clinical Trial: NCT07669467

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

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:Natureceuticals Sdn Bhd
Information Provided By:Natureceuticals Sdn Bhd
Last Update Posted:2026-08-25

Study Overview

Brief 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.

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

Conditions

Fatigue Related to Cancer Treatment, Breast Cancer

Intervention / Treatment

  • Drug: Nuvastatic 300
  • Drug: Placebo

Other Study ID Numbers

  • EBCT003
  • NatureCeuticals Sdn Bhd

Start Date (Actual)

2025-10-01

Primary Completion Date (Estimated)

2026-10-30

Study Completion Date (Estimated)

2026-10-30

Enrollment (Estimated)

250

Study Type

Interventional

Phase

Phase 3