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Clinical Trials in India / NCT07669519
Recruiting Phase 3

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

NCT07669519 · tracked via the Priya Life Science India tracker
Sponsor
Natureceuticals Sdn Bhd
Phase
Phase 3
Started
2025-08-18
Last updated
2026-08-25

Condition(s) studied

FatigueColon Cancer

Investigational drug(s) / intervention(s)

Nuvastatic™Placebo

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male and female Patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study. 2. Patients with colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively. 3. Patients must have a confirmed diagnosis of colon cancer as per standard guideline. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening. 5. The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening. 6. Life expectancy ≥ 6 months, as per Investigator's judgment 7. Patients with co-morbidities or medical conditions including Type 2 DM, hypertension and are deemed stable by the investigator can be included in the study 8. At screening patients with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included. 9. Starting first-line chemo Exclusion Criteria: 1. 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. 2. Patients who have stage IV Disease 3. Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with study drug. 4. Prior metastatic chemo, targeted/immunotherapy, severe comorbidities 5. Female patients who are pregnant or breast-feeding. 6. Patients with known hepatitis C virus, hepatitis B virus, HIV infection. 7. 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. 8. Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. ' 9. Patients with planned therapy or treatment with another investigational agent. 10. 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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Department of Medical Oncology (In Charge - Oncology Unit) Srikakulam Andhra Pradesh Recruiting
Hanji Cancer Centre Belagavi Karnataka Recruiting
K.R. Hospital, Mysore Medical College & Research Institute Mysuru Karnataka Recruiting
Onco- Life Cancer Satara Maharashtra Recruiting
Onco-Life Cancer Centre, Pvt. Ltd Talegaon Dābhāde Maharashtra Recruiting
Avicenna Hospital Lucknow Uttar Pradesh Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07669519 on ClinicalTrials.gov ↗ ← All trials in India