Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Nuvastatic 1000mg Sachet: Nuvastatic 1000mg Sachets to be consumed after meal
1 Sachet 3 times a day to be consumed for 3 cycles(Eah cycle 21 days) to be taken with water as suggeste
Sponsors
Natureceuticals Sdn Bhd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female Patients who are greater than or equal to 18 and ;less than or equal to 65 years of age who are willing to voluntarily provide consent for participation in the study 2 Patients with colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively 3 Patients must have a confirmed diagnosis of colon cancer as per standard guideline 4 Eastern Cooperative Oncology Group performance status of 0 to 2 at Screening 5 The patient has stable haemoglobin greater than or equal to 9 g per dL throughout the screening 6 Life expectancy greater than or equal 6 months as per Investigators judgment 7 Patients with comorbidities or medical conditions including Type 2 DM hypertension and are deemed stable by the investigator can be included in the study 8 At screening patients with stable fatigue has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included 9 Starting firstline chemo
Exclusion criteria
Exclusion criteria: 1 Patients who have any untreated reversible medical condition which may cause fatigue example metabolic disturbance infection endocrine abnormalities as per the Investigators clinical judgment 2 Patients who have stage IV Disease 3 Patients who have received concurrent stimulant medication example dextroamphetamine or methylphenidate during the screening period or any medication which may interfere with study drug 4 Prior metastatic chemo targeted immunotherapy severe comorbidities 5 Female patients who are pregnant or breast feeding 6 Patients with known hepatitis C virus hepatitis B virus HIV infection 7 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 8 Patients with uncontrolled pain who in the opinion of the Investigator are not eligible for the study 9 Patients with planned therapy or treatment with another investigational agent 10 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: 1 from screening to end of treatment for total( 3 cycles) 9 weeks of treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in serum CEA & CA125 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 version 5Timepoint: 1 to 4- screening to end of treatment for total( 3 cycles) 9 weeks of treatment period 5 Screening to End of the study total 12 weeks of period | — |
Countries
India
Contacts
Public ContactMr Chandu Gangadhar Devanpally
Ardent Clinical Research Services
Outcome results
None listed