NCT07669519 Evaluation of NuvastaticTM in Reducing Cancer-Related Fatigue in Stage IV Colon Cancer Patients Undergoing First-Line Chemotherapy
| NCT ID | NCT07669519 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Natureceuticals Sdn Bhd |
| Condition | Fatigue |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2025-08-18 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07669519 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Fatigue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07669519 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT07669519 currently recruiting?
Yes, NCT07669519 is actively recruiting participants. Contact the research team at amanharvard2020@outlook.com for enrollment information.
Where is the NCT07669519 trial being conducted?
This trial is being conducted at Srikakulam, India, Belagavi, India, Mysuru, India, Satara, India and 2 additional locations.
Who is sponsoring the NCT07669519 clinical trial?
NCT07669519 is sponsored by Natureceuticals Sdn Bhd. The trial plans to enroll 180 participants.