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Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Stage IV Colon Cancer Patients Undergoing First-Line Chemotherapy
Sponsor: Natureceuticals Sdn Bhd
Summary
The goal of this clinical trial is to evaluate whether Nuvastatic 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 significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic safe and well tolerated in this patient population? Researchers will compare Nuvastatic vs placebo to see if Nuvastatic improves fatigue scores and maintains an acceptable safety profile. Participants will: Receive Nuvastatic or placebo sachets (3 times per day) for 3 cycles of 20 days each (total \~60 treatment days). Continue their standard first-line chemotherapy regimen. Provide blood samples for biomarkers (CEA, CA-125) at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.
Official title: Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Stage IV Colon Cancer Patients Undergoing First-Line Chemotherapy
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-08-18
Completion Date
2027-03-31
Last Updated
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
Nuvastatic™
1000mg Sachet, (1 sachet X 3 times a day)
Placebo
1000mg sachet, (1 sachet X 3 times a day)
Locations (6)
Department of Medical Oncology (In Charge - Oncology Unit)
Srikakulam, Andhra Pradesh, India
Hanji Cancer Centre
Belagavi, Karnataka, India
K.R. Hospital, Mysore Medical College & Research Institute
Mysuru, Karnataka, India
Onco- Life Cancer
Satara, Maharashtra, India
Onco-Life Cancer Centre, Pvt. Ltd
Talegaon Dābhāde, Maharashtra, India
Avicenna Hospital
Lucknow, Uttar Pradesh, India