Actively Recruiting
Study Evaluating Nuvastatic 300mg Capsules to Reduce Fatigue in Adults with Metastatic Colon Cancer Receiving Standard Chemotherapy
Led by Natureceuticals Sdn Bhd · Updated on 2026-06-25
250
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Nuvastatic 300 capsule on reducing fatigue related to cancer treatment in adults with metastatic colon cancer who are undergoing first-line chemotherapy. The main goals are to determine if Nuvastatic 300 capsule can significantly reduce cancer-related fatigue compared to a placebo and to assess its safety and tolerability in this patient group. This is a phase III randomized, double-blind, placebo-controlled study sponsored by Natureceuticals Sdn Bhd. Participants will receive either Nuvastatic 300 capsules or placebo capsules, taken three times daily for six cycles lasting about 20 days each, totaling approximately 120 treatment days. All participants will continue their standard chemotherapy during the trial. Blood samples will be collected at screening and at the end of treatment to monitor health and treatment effects. During the study, participants will complete diaries and fatigue assessments according to the protocol. Researchers will measure reduction in cancer-related fatigue from screening to the end of treatment, as well as overall quality of life and functional improvements. The trial includes safety monitoring and will last about six months from screening through treatment completion.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 to 65 years willing to provide consent
- Confirmed diagnosis of metastatic colorectal cancer
- Planned or scheduled to receive standard chemotherapy for at least 6 cycles
- At least one tumor lesion 1 cm or larger visible on CT or MRI
- ECOG performance status of 0 to 2 at screening
- Life expectancy of at least 6 months as judged by investigator
- Stable hemoglobin level of 9 g/dL or higher during screening
- Patients with stable co-morbidities like type 2 diabetes or hypertension may be included
You will not qualify if you...
- Untreated reversible medical conditions causing fatigue (e.g., metabolic disturbances, infections)
- Inability to understand local languages for study evaluations
- Use of stimulant medications or drugs interfering with study drug during screening
- Delays in chemotherapy extending screening beyond 21 days
- Known central nervous system metastases
- Serious uncontrolled medical or psychiatric disorders affecting safety or participation
- Pregnancy or breastfeeding
- Known infections with hepatitis B, hepatitis C, or HIV
- Severe nausea, vomiting, or gastrointestinal disorders interfering with drug absorption
- Uncontrolled pain judged unsuitable by investigator
- Known allergies to study drug components or placebo ingredients
- Planned or recent use of other investigational agents within 4 weeks prior to screening
Research Team
A
Aman Shah Abdul Majid, MBChB, DPhil
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