A Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative, Phase III Study to Evaluate the Efficacy and Safety of Nuvastatic® 300mg Capsule in Reducing Cancer-Tumor in Patients With Metastatic Colorectal Cancer Receiving Standard Chemotherapy. (NuvastaticTM)
2026年6月22日 更新者：Natureceuticals Sdn Bhd
The goal of this clinical trial is to evaluate whether Nuvastatic 300 capsule 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 300 capsule significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic 300 capsule safe and well tolerated in this patient population?
Researchers will compare Nuvastatic 300 capsule vs placebo to see if Nuvastatic 300 capsule improves fatigue scores and maintains an acceptable safety profile.
Participants will:
Receive Nuvastatic 300 capsule or placebo capsules (3 times per day) for 6 cycles of 20 days each (total ~120 treatment days).
Continue their standard first-line chemotherapy regimen. Provide blood samples assessment at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.
研究概览
研究类型
介入性
注册 (估计的)
250
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Aman Shah Abdul Majid, MBChB, DPhil
- 电话号码：+605-2490500
- 邮箱：amanharvard2020@outlook.com
学习地点
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Andhra Pradesh
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Visakhapatnam、Andhra Pradesh、印度、530040
- 招聘中
- Omega Hospital Chinna Gadhili
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接触：
- Dr Bella Ravi Shankar
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Karnataka
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Mysore、Karnataka、印度、570001
- 招聘中
- K R Hospital
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接触：
- Dr. Vikas L
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Maharashtra
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Jalgaon、Maharashtra、印度、425001
- 招聘中
- Jeevanjyoti Cancer Hospital
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接触：
- Dr. Chaudhari Nitin Laxman
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Pune、Maharashtra、印度、411027
- 招聘中
- Sangavi Multispeciality Hospital Pvt. Ltd,
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接触：
- Dr. Nikhil Mallinath Shirsi
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Tamil Nadu
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Erode、Tamil Nadu、印度、638012
- 招聘中
- Erode Cancer Care Centre
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接触：
- Dr. K. Velavan
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Uttar Pradesh
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Kanpur、Uttar Pradesh、印度
- 招聘中
- International Oncology Cancer Tower 1
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接触：
- Dr. Sachin Anand Prakash
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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 metastatic colorectal cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively.
- Patients must have a confirmed diagnosis of metastatic colorectal cancer as per standard guidelines.
- Patients must have at least one tumor lesion with ≥ 1cm in one dimension that is radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at Screening.
- Life expectancy ≥ 6 months, as per investigator's judgment.
- The patient has stable hemoglobin (≥ 9 g/dL)throughout the screening.
- Patients with co-morbidities or medical conditions including Type 2 diabetes mellitus (DM), hypertension who are deemed stable by the investigator can be included in the study.
Exclusion Criteria:
- 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 with an inability to understand local language(s) for scales used for evaluations, i.e., EORTC QLQ-C30, BFI, SF-36 and VAS-F.
- Patients who have received concurrent stimulant medication (e.g. dextroamphetamine or methylphenidate) during the screening period or any medication which may interfere with the study drug.
- Patients with any delay in chemotherapy treatment such that the screening period extends beyond 21 days.
- Patients with known central nervous system (CNS) are involved by metastatic cancer.
- 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 patient's safety or study participation and conduct.
- Female patients who are pregnant or breastfeeding.
- 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 known hypersensitivity or intolerance of rosmarinic acid, caffeic acid, and other related phenolic compounds as well as excipients in the Nuvastatic® 300 mg or placebo treatment.
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
安慰剂胶囊
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300mg capsule, (3 capsules X 3 times a day)
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实验性的：Nuvastatic 300
Nuvastatic™ 300 capsule
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300mg capsule, (3 capsules X 3 times a day)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
大体时间：From Screening to EOT (about 6 months)
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The primary outcome measure is the intra-individual changes in the Brief Fatigue Inventory (BFI) fatigue scale
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From Screening to EOT (about 6 months)
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Reduction in cancer-related fatigue in breast cancer patients undergoing first-line chemotherapy, assessed after treatment with Nuvastatic versus placebo.
大体时间：From Screening to EOT (about 6 months)
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The primary outcome measure is the intra-individual changes in the Visual Analogue Fatigue Scale (VAFS)
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From Screening to EOT (about 6 months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall QoL and functional improvement
大体时间：at baseline and at end of the study (about 6 months)
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The secondary outcome measure is the overall QoL improvement using the medical outcome scale Short Form-36 (SF-36).
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at baseline and at end of the study (about 6 months)
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Overall QoL and functional Improvement
大体时间：At baseline and at end of treatment (about 6 months)
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ECOG scores will be compared at baseline and at end of the study.
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At baseline and at end of treatment (about 6 months)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年10月1日
初级完成 (估计的)
2026年10月31日
研究完成 (估计的)
2026年11月30日
研究注册日期
首次提交
2026年1月8日
首先提交符合 QC 标准的
2026年6月22日
首次发布 (实际的)
2026年6月25日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月22日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.