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. (NuvastaticTM)

June 22, 2026 updated by: Natureceuticals Sdn Bhd

The goal of this clinical trial is to evaluate whether Nuvastatic 300 capsule 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 300 capsule significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic 300 capsule safe and well tolerated in this patient population?

Researchers will compare Nuvastatic 300 capsule vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.

Participants will:

Receive Nuvastatic 300 capsule or placebo capsules (3 times per day) for 6 cycles of 20 days each (total ~120 treatment days).

Continue their standard first-line chemotherapy regimen. Provide blood samples assessment at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Andhra Pradesh
      • Visakhapatnam, Andhra Pradesh, India, 530040
        • Recruiting
        • Omega Hospital Chinna Gadhili
        • Contact:
          • Dr Bella Ravi Shankar
    • Karnataka
      • Mysore, Karnataka, India, 570001
        • Recruiting
        • K R Hospital
        • Contact:
          • Dr. Vikas L
    • Maharashtra
      • Jalgaon, Maharashtra, India, 425001
        • Recruiting
        • Jeevanjyoti Cancer Hospital
        • Contact:
          • Dr. Chaudhari Nitin Laxman
      • Pune, Maharashtra, India, 411027
        • Recruiting
        • Sangavi Multispeciality Hospital Pvt. Ltd,
        • Contact:
          • Dr. Nikhil Mallinath Shirsi
    • Tamil Nadu
      • Erode, Tamil Nadu, India, 638012
        • Recruiting
        • Erode Cancer Care Centre
        • Contact:
          • Dr. K. Velavan
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India
        • Recruiting
        • International Oncology Cancer Tower 1
        • Contact:
          • Dr. Sachin Anand Prakash

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 metastatic colorectal cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively.
  • Patients must have a confirmed diagnosis of metastatic colorectal cancer as per standard guidelines.
  • Patients must have at least one tumor lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
  • Life expectancy ≥ 6 months, as per investigator's judgment.
  • The patient has stable hemoglobin (≥ 9 g/dL)throughout the screening.
  • Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM), hypertension who are deemed stable by the investigator can be included in the study.

Exclusion Criteria:

  • 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 with an inability to understand local language(s) for scales used for evaluations, i.e., EORTC QLQ-C30, BFI, SF-36 and VAS-F.
  • Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.
  • Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.
  • Patients with known central nervous system (CNS) are involved by metastatic cancer.
  • Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator may affect the patient's safety or study participation and conduct.
  • Female patients who are pregnant or breastfeeding.
  • Patients with known hepatitis C virus, hepatitis B virus, HIV infection.
  • Patients who have nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the investigator.
  • Patients with uncontrolled pain who, in the opinion of the investigator, are not eligible for the study.
  • Patients with known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.
  • Patients with planned therapy or treatment with another investigational agent.
  • Previous exposure to any investigational agent within 4 weeks prior to screening, or planned administration of an Investigational agent, other than as specified by this protocol, during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo
300mg capsule, (3 capsules X 3 times a day)
Experimental: Nuvastatic 300
Nuvastatic™ 300 capsule
Drug: Nuvastatic 300
300mg capsule, (3 capsules X 3 times a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Time Frame: From Screening to EOT (about 6 months)
The primary outcome measure is the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale
From Screening to EOT (about 6 months)
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Time Frame: From Screening to EOT (about 6 months)
The primary outcome measure is the intra-individual changes in the Visual Analogue Fatigue Scale (VAFS)
From Screening to EOT (about 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall QoL and functional improvement
Time Frame: at baseline and at end of the study (about 6 months)
The secondary outcome measure is the overall QoL improvement using the medical outcome scale Short Form-36 (SF-36).
at baseline and at end of the study (about 6 months)
Overall QoL and functional Improvement
Time Frame: At baseline and at end of treatment (about 6 months)
ECOG scores will be compared at baseline and at end of the study.
At baseline and at end of treatment (about 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natureceuticals Sdn Bhd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBCT004
  • NatureCeuticals Sdn Bhd (Other Grant/Funding Number: NatureCeuticals Sdn Bhd)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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