Study Evaluating Nuvastatic 300mg Capsules to Reduce Fatigue in Adults with Metastatic Colon Cancer Receiving Standard Chemotherapy

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.

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.