Nuvastatic 300mg Capsule in metastatic colorectal cancer patients on first-line chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase III, randomized, double-blind, placebo-controlled study comparing Nuvastatic 300mg capsules to placebo in adults with metastatic colorectal cancer undergoing standard first-line chemotherapy. Participants are assigned to take the study capsule or placebo three times daily for six 20-day cycles, in addition to their regular chemotherapy. Blood samples are collected at screening and end of treatment, and patients complete fatigue diaries and assessments throughout the protocol. The primary objective is to determine if Nuvastatic reduces cancer-related fatigue while maintaining an acceptable safety profile. Key eligibility includes age 18-65, measurable disease, ECOG 0-2, adequate hemoglobin, and stable comorbidities as judged by investigators. Locations include several hospitals in India, with Natureceuticals Sdn Bhd as lead sponsor.

Why it matters

Who can join: the full rules

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.

Where it's running

• Omega Hospital Chinna Gadhili
  Visakhapatnam, Andhra Pradesh, India Recruiting
• K R Hospital
  Mysore, Karnataka, India Recruiting
• Jeevanjyoti Cancer Hospital
  Jalgaon, Maharashtra, India Recruiting
• Sangavi Multispeciality Hospital Pvt. Ltd,
  Pune, Maharashtra, India Recruiting
• Erode Cancer Care Centre
  Erode, Tamil Nadu, India Recruiting
• International Oncology Cancer Tower 1
  Kanpur, Uttar Pradesh, India Recruiting

Study contacts

• Study coordinator: Aman Shah Abdul Majid, MBChB, DPhil
• Email: amanharvard2020@outlook.com
• Phone: +605-2490500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.