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RECRUITING
NCT07669467
PHASE3

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

Sponsor: Natureceuticals Sdn Bhd

View on ClinicalTrials.gov

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

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2025-10-01

Completion Date

2026-10-30

Last Updated

2026-06-25

Healthy Volunteers

No

Interventions

DRUG

Nuvastatic 300

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

DRUG

Placebo

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