Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer (NCT07669467) | Clinical Trial Compass
RecruitingPhase 3
Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer
India250 participantsStarted 2025-10-01
Plain-language summary
The goal of this clinical trial is to evaluate whether Nuvastatic 300 mg capsules 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 300 mg capsules significantly reduce cancer-related fatigue compared to placebo?
* Is Nuvastatic 300 mg capsules safe and well tolerated in this patient population?
Researchers will compare Nuvastatic 300 mg capsules vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.
Participants will:
* Receive Nuvastatic 300 mg capsules or placebo capsules (3 times per day) for 3 cycles of 20 days each (total \~60 treatment days).
* Continue their standard first-line chemotherapy regimen.
* Provide blood sample assessments at Screening and End of Treatment.
* Complete patient diaries and fatigue assessments as per protocol.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged ≥ 18 years and ≤ 65 years who are willing to voluntarily provide consent for participation in the study.
* Patients with confirmed triple negative metastatic breast cancer who are planned or scheduled to receive standard chemotherapy treatment for at least 4 to 6 cycles respectively.
* Patients must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guidelines.
* Patients must have at least one tumour 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.
* The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
* Life expectancy ≥ 6 months, as per the investigator's judgment.
* Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM) and hypertension who are deemed stable by the investigator can be included in the study.
* At screening, patients with stable fatigue, newly developed fatigue, or worsening fatigue scores as assessed by the Brief Fatigue Inventory (BFI) should be included.
Exclusion Criteria:
* Patients who have any untreated reversible medical condition which may cause fatigue (e.g. major metabolic or electrolyte disturbance, active infection, endocrine abnormalities) as per the investigator's clinical judgment.
* Patients with an inability to understand local language(s)…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
Timeframe: From Screening to EOT (about 6 months)
2
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.