Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer-Related Fatigue in Colon Cancer Patients Undergoing First-Line Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 6
研究概览
简要总结
The goal of this clinical trial is to evaluate whether Nuvastatic can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.
The main questions it aims to answer are:
Does Nuvastatic significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic safe and well tolerated in this patient population?
Researchers will compare Nuvastatic vs placebo to see if Nuvastatic improves fatigue scores and maintains an acceptable safety profile.
Participants will:
Receive Nuvastatic or placebo sachets (3 times per day) for 3 cycles of 20 days each (total ~60 treatment days).
Continue their standard first-line chemotherapy regimen. Provide blood samples for biomarkers (CEA, CA-125) at Screening and End of Treatment.
Complete patient diaries and fatigue assessments as per protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Details of the investigational product (Nuvastatic or placebo) are concealed from both the study investigators and the trial participants. Each enrolled subject receives a randomization code allocated sequentially through IWRS.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Patients who are ≥18 and ≤65 years of age, who are willing to voluntarily provide consent for participation in the study.
- •Patients with colon cancer planned or scheduled to receive standard chemotherapy treatment for at least 3 cycles respectively.
- •Patients must have a confirmed diagnosis of colon cancer as per standard guideline.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
- •The patient has stable haemoglobin (≥ 9 g/dL) throughout the screening.
- •Life expectancy ≥ 6 months, as per Investigator's judgment
- •Patients with co-morbidities or medical conditions including Type 2 DM, hypertension and are deemed stable by the investigator can be included in the study
- •At screening patients with stable fatigue, has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included.
- •Starting first-line chemo
排除标准
- •Patients who have any untreated reversible medical condition which may cause fatigue (e.g. metabolic disturbance, infection, endocrine abnormalities) as per the Investigator's clinical judgment.
- •Patients who have stage IV Disease
- •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.
- •Prior metastatic chemo, targeted/immunotherapy, severe comorbidities
- •Female patients who are pregnant or breast-feeding.
- •Patients with known hepatitis C virus, hepatitis B virus, HIV infection.
- •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.
- •Patients with uncontrolled pain, who in the opinion of the Investigator are not eligible for the study. '
- •Patients with planned therapy or treatment with another investigational agent.
- •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.