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New treatment option for Fatigue Related to Cancer Treatment
Official title Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer
ClinicalTrials.gov ID: NCT07669467
What this study is testing
What is Nuvastatic 300?
Nuvastatic 300 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for fatigue related to cancer treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at screening.
You likely can't join if
- Patients who have any untreated reversible medical condition which may cause fatigue (e.g. major metabolic or electrolyte disturbance, active...
- Patients with an inability to understand local language(s) for scales used for evaluations i.e. VAFS, BFI AND SF-36.
- Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication...
- Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.
- Patients with known central nervous system (CNS) involvement.
- Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the...
See the full eligibility 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.
- 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...
- Patients with an inability to understand local language(s) for scales used for evaluations i.e. VAFS, BFI AND SF-36.
- Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.
- Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.
- Patients with known central nervous system (CNS) involvement.
- Patients with any serious, uncontrolled, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the investigator, may affect the patient's safety or study participation and...
- Female patients who are pregnant or breastfeeding.
- 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.
- Patients with uncontrolled pain, who in the opinion of the investigator are not eligible for the study.
- Patients with known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Visakhapatnam, Andhra Pradesh, India
- Mysore, Karnataka, India
- Jalgaon, Maharashtra, India
- Pune, Mahrasta, India
- Erode, Tamil Nadu, India
- Kanpur, Uttar Pradesh, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Visakhapatnam, Andhra Pradesh, India; Mysore, Karnataka, India; Jalgaon, Maharashtra, India; Pune, Mahrasta, India; Erode, Tamil Nadu, India; Kanpur, Uttar Pradesh, India. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.