NCT07669506CompletedPhase 3
Phase III Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Breast Cancer Patients Undergoing Chemotherapy
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Natureceuticals Sdn Bhd
- Enrollment
- 180
- Locations
- 7
Study Overview
Brief Summary
The goal of this clinical trial is to determine whether Nuvastatic™ can reduce cancer-related fatigue and improve quality of life in adult female patients with breast cancer undergoing standard chemotherapy.
The main questions it aims to answer are:
Does Nuvastatic™ reduce cancer-related fatigue as measured by change in the Brief Fatigue Inventory (BFI) from baseline to end of treatment? Does Nuvastatic™ improve quality of life, safety outcomes, and clinical parameters compared with placebo during chemotherapy?
Researchers will compare patients receiving Nuvastatic™ plus standard chemotherapy with patients receiving placebo plus standard chemotherapy to see if Nuvastatic™ leads to greater reductions in fatigue, improved quality of life, and acceptable safety while undergoing treatment.
Participants will:
- Receive Nuvastatic™ or matching placebo as a 1000 mg effervescent sachet taken three times daily after meals for three chemotherapy cycles
- Continue their standard-of-care chemotherapy as prescribed by their treating physician
- Complete fatigue and quality-of-life questionnaires (BFI, SF-36, EORTC QLQ-C30)
- Undergo routine clinical assessments, laboratory tests, ECGs, and safety monitoring
- Undergo CT imaging for tumor response assessment according to RECIST 1.1
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female Patients aged ≥ 18 years and ≤65 years who are willing to voluntarily provide consent for participation in the study.
- •Confirm diagnosis of Breast cancer as per the available Report.
- •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 deem stable by the investigator can be included in the study
- •At screening patient with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by 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 judgement.
- •Patient who have stage IV Disease
- •Female patients who are pregnant or breast-feeding.
- •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 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.
Investigators
Study Sites (7)
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