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

NCT07669519 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-06-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nuvastatic™

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Natureceuticals Sdn Bhd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07669519 on ClinicalTrials.gov