Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: Nuvastatic® 1000 mg sachet containing effervescent powder manufactured by Natureceuticals Sdn Bhd, Malaysia: 1. Nuvastatic® is to be consumed after meal, 1 sachet � 5 times a day.
2.
Sponsors
Natureceuticals Sdn Bhd
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria: 1. Male or female patient >= 18 years of age, who are willing to voluntarily provide consent for participation in the study. 2. Patient with metastatic colorectal cancer who is receiving or is scheduled to receive 5-fluorouracil treatment for at least 6 cycles. 3. Patient must have a confirmed diagnosis of metastatic colorectal cancer. 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. Female patient of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue the use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. 9. Male patient not surgically sterile or who are capable of producing offspring must agree to practice abstinence or use a barrier method of birth control and must agree to continue the use of this method for the duration of the study and for 30 days after participation in the study. Inclusion criteria check prior to randomization (Day 1, Cycle 2): All of the above + 10. Prior to randomization, the patient has already received >= 1 cycle (21-days) of chemotherapy. 11. Patient has a newly developed fatigue OR worsening of fatigue scoring as assessed by FSS; when compared to the screening (pre-Cycle 1) achieving.
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. FSS, FACIT-F, VAFS, BFI. 3. Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period. 4. Patients with any delay in chemotherapy treatment such that the screening period extends beyond 28 days. 5. Patients with known 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. Serum hepatitis B surface antigen (HBsAg) must be negative. 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® or Placebo treatment. 12. Patients with planned or currently receiving concurrent radiation 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 Chemotherapy-induced fatigue as assessed by FSS (Fatigue severity scale)Timepoint: Baseline (Cycle 2), and at each cycle till 6 Cycles, EOT and Follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in Chemotherapy-induced fatigue as assessed by FACIT-F scale(Functional Assessment of Chronic Illness Therapy - fatigue scale), BFI (Brief Fatigue Inventory Questionnaire) and VAFS (Visual analogue fatigue scale) 2. Reduction in Urine F2-isoprostane levels as markers of oxidative stressTimepoint: 1. Baseline (Cycle 2), and at each cycle till 6 Cycles, EOT and Follow-up. 2. Baseline (Cycle 2), Cycle 4, Cycle 6, EOT and Follow-up | — |
Countries
Australia, India
Contacts
Public ContactMeena Dalal
Green Remedies
Outcome results
None listed