RecruitingPhase 3NCT07669519

Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy

Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy


Sponsor

Natureceuticals Sdn Bhd

Enrollment

180 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Nuvastatic™ and a drug called Placebo for people with colon cancer and fatigue. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNuvastatic™

1000mg Sachet, (1 sachet X 3 times a day)

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07669519


Related Trials