RecruitingPhase 3NCT07669467

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

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


Sponsor

Natureceuticals Sdn Bhd

Enrollment

250 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nuvastatic 300 and a drug called Placebo for people with breast cancer and fatigue related to cancer treatment. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNuvastatic 300

300mg capsule, (3 capsules X 3 times a day)

DRUGPlacebo

300mg capsule, (3 capsules X 3 times a day)


Locations(6)

Omega Hospital Chinna Gadhili

Visakhapatnam, Andhra Pradesh, India

K R Hospital

Mysore, Karnataka, India

Jeevanjyoti Cancer Hospital

Jalgaon, Maharashtra, India

Sangavi Multispeciality Hospital Pvt. Ltd,

Pune, Mahrasta, India

Erode Cancer Care Centre

Erode, Tamil Nadu, India

International Oncology Cancer Tower 1

Kanpur, Uttar Pradesh, India

View Full Details on ClinicalTrials.gov

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NCT07669467


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