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NCT Number: NCT07669454

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.

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Omega Hospital Chinna Gadhili, Visakhapatnam, Andhra Pradesh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nuvastatic 300

Drug

300mg capsule, (3 capsules X 3 times a day)

Placebo

Drug

300mg capsule, (3 capsules X 3 times a day)

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aman Shah Abdul Majid, MBChB, DPhil

CONTACT

[email protected]

+605-2490500

Sponsors and collaborators

Lead sponsor

Natureceuticals Sdn Bhd

Industry

Registry information

Acronym: NuvastaticTM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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