Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: NuvastaticÃ?® 300 mg capsules containing 300 mg standardized extract of Orthosiphon stamineus: NuvastaticÃ?® 300mg dose to be consumed after meal 3 capsules Ã?â?? 3 times a day Total
Sponsors
Natureceuticals Sdn Bhd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients greater than equal to 18 years and less than equal to 65 of age who are willing to voluntarily provide consent for participation in the study 2 Patients with confirmed triple negative metastatic breast cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively 3 Patient must have a confirmed diagnosis of triple negative metastatic breast cancer as per standard guideline 4 Patient 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) 5 Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening 6 Life expectancy � 6 months as per Investigators judgment 7 The patient has stable hemoglobin (� 9 g/dL) throughout the screening 8 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 9 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
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 Investigators clinical judgment 2 Patients with an inability to understand local language(s) for scales used for evaluations i e VAFS BFI AND SF-36 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 Patients with any delay in chemotherapy treatment such that the screening period extends beyond 28 days 5 Patients with known central nervous system (CNS) involvement by metastatic cancer 6 Patients with any serious, uncontrolled nonmalignant medical or psychiatric disorder or any other medical condition which in the opinion of the Investigator may affect the patients safety or study participation and conduct 7 Female patients who are pregnant or breast feeding 8 Patients with known hepatitis C virus hepatitis B virus HIV infection 9 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 10 Patients with uncontrolled pain who in the opinion of the Investigator are not eligible for the study 11 Patients with known hypersensitivity or intolerance of rosmarinic acid caffeic acid and other related phenolic compounds as well as excipients in the Nuvastatic�® 300mg or Placebo treatment 12 Patients with planned therapy or treatment with another investigational agent 13 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 |
|---|---|
| 1 Improvement in chemotherapy induced fatigue as assessed by 1 BFI 2 Brief Fatigue Inventory 3 Visual analogue scale fatigue SF-36 4 Short form-36 Quality of Life Timepoint: Baseline to visit 6 and after 3 months of EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Improvement in RECIST 1.1 score 2 Incidence of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0Timepoint: Baseline to visit 6 and after 3 months of EOT | — |
Countries
India
Contacts
Public ContactMr Chandu Gangadhar Devanpally
Ardent Clinical Research Services
Outcome results
None listed