See if Nuvastatic helps with cancer-related fatigue in colon 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 3, randomized, double-blind, placebo-controlled study evaluating Nuvastatic for fatigue reduction in adults with colon cancer undergoing first-line chemotherapy. Participants will take Nuvastatic or placebo three times daily for about 60 treatment days across three 20-day cycles while continuing standard chemotherapy. The study will monitor fatigue using patient diaries and biomarkers (CEA, CA-125) at screening and end of treatment, and will assess safety and tolerability alongside fatigue outcomes. Eligible patients are adults 18–65 with colon cancer, ECOG 0–2, stable hemoglobin, and planned for at least three chemotherapy cycles; exclusions include any untreated reversi (incomplete criterion). The trial is conducted at multiple oncology centers in India and uses standard safety monitoring throughout.

Why it matters

Who can join: the full rules

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.

Where it's running

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