NCT07669519RecruitingPhase 3
Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy
Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 23 Dec 2025
- Start date
- 18 Aug 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Natureceuticals Sdn Bhd
- Diseases
- Colorectal cancer
- NCT number
- NCT07669519
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 180
- From 18 Aug 2025 to the primary completion date, 31 Mar 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Prior metastatic chemo, targeted/immunotherapy, severe comorbidities
- 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.
Other illness
- 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 who have stage IV Disease
- 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.
Other
- Female patients who are pregnant or breast-feeding.
- Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. '
Who the study is looking for
- 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 colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively.
- Patients must have a confirmed diagnosis of colon cancer as per standard guideline.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
- The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
- Life expectancy ≥ 6 months, as per Investigator's judgment
- 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
- At screening patients with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included.
- Starting first-line chemo
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hanji Cancer Centre Coordinator of this site? Confirm its status | Belagavi | India | Recruiting |
| Avicenna Hospital Coordinator of this site? Confirm its status | Lucknow | India | Recruiting |
| K.R. Hospital, Mysore Medical College & Research Institute Coordinator of this site? Confirm its status | Mysuru | India | Recruiting |
| Onco- Life Cancer Coordinator of this site? Confirm its status | Satara | India | Recruiting |
| Department of Medical Oncology (In Charge - Oncology Unit) Coordinator of this site? Confirm its status | Srikakulam | India | Recruiting |
| Onco-Life Cancer Centre, Pvt. Ltd Coordinator of this site? Confirm its status | Talegaon Dābhāde | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.