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Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer
Sponsor: Natureceuticals Sdn Bhd
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
Nuvastatic 300
300mg capsule, (3 capsules X 3 times a day)
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