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RECRUITING
NCT07669519
PHASE3

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

Sponsor: Natureceuticals Sdn Bhd

View on ClinicalTrials.gov

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

Interventions

DRUG

Nuvastatic™

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

DRUG

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