Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: NuvastaticTM 1000mg Sachet: Participants will be asked to consume 1000mg sachet effervescent powder dissolved in 250 ml of water 3 times a day after meal for total 70 days
(1 sachet X 3
Sponsors
Natureceuticals Sdn Bhd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Female Patients aged greater than or equal to 18 years and less than or equal to65 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 performance status of 0 to 2 at Screening 4 The patient has stable haemoglobin greater than or equal to 9 g per dL throughout the screening 5 Life expectancy greater than or equal to 6 months as per Investigator judgment 6 Patients with comorbidities 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
Exclusion criteria: 1 Patients who have any untreated reversible medical condition which may cause fatigue example major metabolic or electrolyte disturbance active infection endocrine abnormalities as per the Investigators 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 |
|---|---|
| 1 Change in BFI scoreTimepoint: From Screening to end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in serum CEA and CA15-3 levels 2 Fatigues SF 36 questionnaire 3 Change in the laboratory Parameter 4 Change in Global Health Status QoL score as measured by the EORTC QLQ C30 5 Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 6 RECIST 1.1Timepoint: 1 From screening to EOT 2 From screening to EOT 3 From screening to EOT 4 From screening to EOT 5 From screening to EOT 6 From screening to End of the study | — |
Countries
India
Contacts
Public ContactMr Chandu Gangadhar Devanpally
Ardent Clinical Research Services
Outcome results
None listed