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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300mg Capsule in Reducing Cancer-Tumor in Patients With Metastatic Colorectal Cancer Receiving Standard Chemotherapy.
Sponsor: Natureceuticals Sdn Bhd
Summary
The goal of this clinical trial is to evaluate whether Nuvastatic 300 capsule 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 capsule significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic 300 capsule safe and well tolerated in this patient population? Researchers will compare Nuvastatic 300 capsule vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile. Participants will: Receive Nuvastatic 300 capsule or placebo capsules (3 times per day) for 6 cycles of 20 days each (total \~120 treatment days). Continue their standard first-line chemotherapy regimen. Provide blood samples assessment at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2025-10-01
Completion Date
2026-11-30
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, Maharashtra, India
Erode Cancer Care Centre
Erode, Tamil Nadu, India
International Oncology Cancer Tower 1
Kanpur, Uttar Pradesh, India