A randomized double blind placebo controlled parallel group comparative phase III study to evaluate the efficacy and safety of Nuvastatic® 300mg in reducing cancerinduced fatigue in patients with newly diagnosed chemotherapy naïve nonresectable metastatic colorectal cancer receiving standard chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Improvement in tumor control
研究概览
简要总结
| This is a randomized, double-blind, placebo-controlled, parallel-group assignment, comparative clinical study of Nuvastatic® in patients with newly diagnosed, chemotherapy naïve, non-resectable metastatic colorectal cancer receiving standard chemotherapy. |
Patients with metastatic colorectal cancer who are receiving or are scheduled to receive standard treatment including FOLFOX/FOLFIRI or AT, CAF, FC etc. treatment respectively will be eligible for enrolment in the study. Patients should be scheduled to receive at least 4 chemotherapy cycles 3-weekly (21 days OR 14 days), as per the Investigator’s judgment and standard of care. The screening period will last up to 28 days prior to Cycle 1. Prior to enrolment in the study on Day 1 (Cycle 1), patients will be re-evaluated for inclusion criteria.
Dosing and duration for standard chemotherapy will be at the Investigator’s discretion and standard of care of study centre. A 3-weekly (21 days or 14 days) cycle is assumed but can vary based on the patient requirements and as deemed necessary by the Investigator. The patient will be evaluated for additional chemotherapy cycles as per the study treatment period.
After the completion of the treatment cycles, an end-of-treatment (EOT) assessment will be performed at the end of the last Cycle. A safety follow-up will be conducted 14 days after the EOT. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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.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 Investigator’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.
排除标准
- •1.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.
- •2.Patients with an inability to understand local language(s) for scales used for evaluations i.e. EORTC QLQ-C30, BFI AND SF-
- •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 patient’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.
结局指标
主要结局
Improvement in tumor control
时间窗: From baseline to End of treatment for total 126 days of duration
次要结局
- 1 Improvement in cancer-induced fatigue as assessed by BFI(2 Improvement in VAS-F Visual analogue scale)
研究者
Mr Chandu Gangadhar Devanpally
Ardent Clinical Research Services