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.
Male and female Patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study.
Patients with colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively.
Patients must have a confirmed diagnosis of colon cancer as per standard guideline.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
Patients who have any untreated reversible medical condition which may cause fatigue (e.g. metabolic disturbance, infection, endocrine abnormalities) as per the Investigator's clinical judgment.
Patients who have stage IV Disease
Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with study drug.
Prior metastatic chemo, targeted/immunotherapy, severe comorbidities
Natureceuticals Sdn Bhd
Lead sponsor