A randomized double blind placebo controlled multicenter phase III study to evaluate the efficacy and safety of Nuvastatic® 300 mg in reducing chemotherapy induced fatigue in patients with metastatic triple negative breast cancer receiving standard chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 13
- 主要终点
- 1 Improvement in chemotherapy induced fatigue as assessed by 1 BFI
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group assignment, comparative clinical study of Nuvastatic® 300mg in patients with newly diagnosed, chemotherapy naïve, non-respectable triple negative metastatic breast cancer receiving standard chemotherapy. 1 week prior to initiation of first chemotherapy, patients will be administered with test product in ascending dose.
Patients with triple negative metastatic breast cancer who are receiving or are scheduled to receive standard treatment including Doxorubicin and Cyclophosphamide, 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. Patients meeting the eligibility criteria will be consented and screened for baseline fatigue scores using BFI prior to commencement of their chemotherapy Cycle 1. 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 and change in fatigue severity as per BFI. Patients should still be considered for study enrolment if the fatigue severity as per the BFI has not increased by at least one score from the initial assessment (before Cycle 1) during the screening.
Those with stable fatigue scores, newly developed fatigue or worsening of their fatigue score will be eligible for enrolment in the study and will be randomized to receive Nuvastatic® 300 mg or Placebo in a 1:1 ratio. Dosing and duration for standard chemotherapy will be at the Investigator 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 patients. This is a randomized, double-blind, placebo-controlled, parallel-group assignment, comparative clinical study of Nuvastatic® 300mg in patients with newly diagnosed, chemotherapy naïve, non-resectable triple negative metastatic breast cancer receiving standard chemotherapy. 1 week prior to initiation of first chemotherapy, patients will be administered with test product in ascending dose.
Patients with triple negative metastatic breast cancer who are receiving or are scheduled to receive standard treatment including Doxorubicin and Cyclophosphamide, 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. Patients meeting the eligibility criteria will be consented and screened for baseline fatigue scores using BFI prior to commencement of their chemotherapy Cycle 1. 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 and change in fatigue severity as per BFI. Patients should still be considered for study enrolment if the fatigue severity as per the BFI has not increased by at least one score from the initial assessment (before Cycle 1) during the screening.
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 greater than equal to 18 years and less than equal to 65 of age who are willing to voluntarily provide consent for participation in the study 2 Patients with confirmed triple negative metastatic breast cancer planned or scheduled to receive standard chemotherapy treatment for at least 6 cycles respectively 3 Patient must have a confirmed diagnosis of triple negative metastatic breast 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 Investigators 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 9 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 (e g major metabolic or electrolyte disturbance active infection endocrine abnormalities) as per the Investigators clinical judgment 2 Patients with an inability to understand local language(s) for scales used for evaluations i e VAFS BFI AND SF-36 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 nonmalignant medical or psychiatric disorder or any other medical condition which in the opinion of the Investigator may affect the patients 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
1 Improvement in chemotherapy induced fatigue as assessed by 1 BFI
时间窗: Baseline to visit 6 and after 3 months of EOT
2 Brief Fatigue Inventory
时间窗: Baseline to visit 6 and after 3 months of EOT
3 Visual analogue scale fatigue SF-36
时间窗: Baseline to visit 6 and after 3 months of EOT
4 Short form-36 Quality of Life
时间窗: Baseline to visit 6 and after 3 months of EOT
次要结局
- 1 Improvement in RECIST 1.1 score(2 Incidence of adverse events (AEs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0)
研究者
Ms. Aman Ahlawat
Innayat Medical