Phase III Randomized Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer Related Fatigue in Breast Cancer Patients Undergoing 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, Multi Centre. Study to Evaluate the Efficacy and Safety of NuvastaticTM in Reducing Cancer- Related Fatigue in Breast Cancer Patients Undergoing Chemotherapy.
Patients with breast cancer who are receiving or are scheduled to receive
standard treatment as per the Investigator. treatment respectively will be
eligible for enrolment in the study. Patients should be scheduled to receive atvleast 3 chemotherapy cycles 3-weekly (21 days), as per the Investigator’s judgment and standard of care.
The screening period will last up to 14 days (Day 0) prior to Cycle 1. Prior to enrolment in the study on Day 1 (Cycle 1), patients will be re-evaluated for inclusion criteria.
The dosing and duration for standard chemotherapy will be at the
Investigator’s discretion and standard of care of study center. A 3-weekly (21 days) cycle is assumed but can vary based on the patient’s 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.
Dosage & Administration:
Test Arm:NuvastaticTM 1000mg Sachet.
1 Sachet of NuvastaticTM 1000mg will be consumed by the Subject 3 times a day for a period of 3 Cycles for total 63-70 days including window period.
Reference Arm: Placebo of NuvastaticTM 1000mg Sachet.
1 Sachet of placebo of NuvastaticTM 1000mg will be consumed by the Subject 3 times a day for a period of 3 Cycles for total 63-70 days including window period
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
- Female
入选标准
- •1 Female Patients aged greater than or equal to 18 years and less than or equal to65 years who are willing to voluntarily provide consent for participation in the study 2 Confirm diagnosis of Breast cancer as per the available Report 3 Eastern Cooperative Oncology Group performance status of 0 to 2 at Screening 4 The patient has stable haemoglobin greater than or equal to 9 g per dL throughout the screening 5 Life expectancy greater than or equal to 6 months as per Investigator judgment 6 Patients with comorbidities or medical conditions including Type 2 DM hypertension and are deem stable by the investigator can be included in the study 7 At screening patient with stable fatigue has a newly developed fatigue OR worsening of fatigue scoring as assessed by BFI should be included.
排除标准
- •1 Patients who have any untreated reversible medical condition which may cause fatigue example major metabolic or electrolyte disturbance active infection endocrine abnormalities as per the Investigators clinical judgement 2 Patient who have stage IV Disease 3 Female patients who are pregnant or breast-feeding 4 Patients with known hepatitis C virus, hepatitis B virus HIV infection 5 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 6 Patients with uncontrolled pain who in the opinion of the Investigator are not eligible for the study 7 Patients with planned therapy or treatment with another investigational agent 8 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: From Screening to end of treatment
次要结局
- 1 Change in serum CEA and CA15-3 levels(2 Fatigues SF 36 questionnaire)