Phase III Randomized Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of Nuvastatic™ in Reducing Cancer Related Fatigue in Colon Cancer Patients Undergoing First Line Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- 1 Change in BFI score
研究概览
简要总结
This is a Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nuvastatic™ in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy
TEST: Nuvastatic™ 1000mg Sachet containing effervescent powder proprietary standardized extract of Orthosiphon stamineus (C5OSESW5050ESA) manufactured by Natureceuticals Sdn Bhd, Malaysia.
PLACEBO: Placebo of Nuvastatic™ 1000mg Sachet to be provided by Natureceuticals Sdn. Bhd., Malaysia.
Dosage and Administration:
Nuvastatic™ 1000mg Sachet/Placebo is to be consumed after meal 3 times a day. 1 Sachet X 3 times a day to be consumed for 3 cycles.
To be taken with water as suggested by Principal investigator.
CHEMOTHERAPY:
Colon cancer arm:
The chemotherapy to be used during this study is as per the standard of care of study center, e.g. given for treatment cycles of 3 weeks (21 days) each. Chemotherapy is required to be procured by the patient as part of their routine treatment plan, irrespective of participation in this study. The dose and administration of standard chemotherapy will be managed as per the Investigator’s clinical judgment and in line with the treatment plan for the patient.
The duration of participation for the patient will be approximately 3 months.
The total duration of the study including recruitment, will be approximately 4 to 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1 Change in BFI score
时间窗: 1 from screening to end of treatment for total( 3 cycles) 9 weeks of treatment period
次要结局
- 1 Change in serum CEA & CA125 levels(2 Fatigues SF-36 questionnaire)