Breast Neoplasms, Chemotherapy, Adjuvant, Fatigue, Quality of Life
Conditions
Keywords
Breast Cancer, Cancer-Related Fatigue, Chemotherapy, Nuvastatic™, Randomized Controlled Trial
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
Interventions
DRUGNuvastatic ™
Greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet
DRUGPlacebo
greenhouse-sourced extract 1000mg sachet, or openfield extract 1000mg sachet
Sponsors
Natureceuticals Sdn Bhd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Female Patients aged ≥ 18 years and ≤65 years who are willing to voluntarily provide consent for participation in the study. 2. Confirm diagnosis of Breast cancer as per the available Report. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening. 4. The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening. 5. Life expectancy ≥ 6 months, as per Investigator's judgment 6. 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 7. 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
1. 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. 2. Patient who have stage IV Disease 3. Female patients who are pregnant or breast-feeding. 4. Patients with known hepatitis C virus, hepatitis B virus, HIV infection. 5. 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. 6. Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. ' 7. Patients with planned therapy or treatment with another investigational agent. 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Fatigue Inventory (BFI) score | At baseline until end of treatment at 12 weeks | The primary outcome measure was the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale and Visual Analogue Fatigue Scale (VAFS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall QoL improvement using the medical outcome scale Short Form-36 (SF-36). ECOG scores were compared at baseline and at end of the study. | At baseline and end of treatment at 12 weeks | Secondary Outcome Measures are: Fatigue assessment using SF-36 Questionnaire from screening to EOT. Change in Global Health Status/QoL score as measured by EORTC QLQ-C30 from screening to EOT. Incidence of adverse events (AEs) graded according to CTCAE v5.0. Tumor response assessed by RECIST 1.1 criteria from baseline to EOT. |
| Changes in biomarkers | At baseline and end of treatment at 12 weeks | Change in serum CEA (ng/mL) and CA15-3 (U/mL) levels from screening to EOT. Change in laboratory parameters from screening to EOT. |
Countries
India
Outcome results
None listed