Health Condition 1: K635- Polyp of colon
Conditions
Interventions
Intervention1: Nuvastatic® 300 mg capsules containing 300 mg standardized extract of Orthosiphon stamineus: Nuvastatic® 300mg dose to be consumed after meal 3 capsules � 3 times a day Total 9 capsu
Sponsors
Natureceuticals Sdn Bhd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients >= 18 years of age, who are willing to voluntarily provide consent for participation in the study. 2.Patients with metastatic colorectal cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively. 3.Patient must have a confirmed diagnosis of metastatic colorectal 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 Investigatorâ??s 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
Exclusion criteria
Exclusion criteria: 1.Patients who have any untreated reversible medical condition which may cause fatigue (e.g. metabolic disturbance, infection, endocrine abnormalities) as per the Investigatorâ??s clinical judgment. 2.Patients with an inability to understand local language(s) for scales used for evaluations i.e. EORTC QLQ-C30, 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, non-malignant medical or psychiatric disorder, or any other medical condition which in the opinion of the Investigator may affect the patientâ??s 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 |
|---|---|
| Improvement in tumor controlTimepoint: From baseline to End of treatment for total 126 days of duration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Improvement in cancer-induced fatigue as assessed by BFI 2 Improvement in VAS-F Visual analogue scale 3 Change in Global Health Status/QoL score as measured by the EORTC QLQ-C30 4 Change in SF-36 Physical & Mental Health Composite Scores 5 Incidence of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Timepoint: 1.Baseline to EOT 2.Baseline to EOT 3.Baseline to EOT 4.Baseline to EOT 5.Baseline to EOS | — |
Countries
India
Contacts
Public ContactMr Chandu Gangadhar Devanpally
Ardent Clinical Research Services
Outcome results
None listed