Safety and Clinical Efficacy Evaluation of Awar-awar Leaves (Ficus Septica Burm. F.) Active Fraction Capsule as Chemotherapy Complement in Stage IV Breast Cancer Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Quality of life assessment
研究概览
简要总结
The purpose of this research is to assess the safety profile and clinical benefit of Awar-Awar leaf active fraction as a complementary therapy in chemotherapy of stage IV breast cancer
详细描述
The study uses a double blind design and randomized controlled trial that compares the safety and clinical efficacy profiles of 3 treatment groups (each consists of 97 subjects who received chemotherapy for 6 cycles). The treatment group was given FADA at a dose of 800 mg/day and 2000 mg/day compared to the placebo group. Interim analysis is carried out after 25% of the subjects completed 3 cycles of chemotherapy; whereas interim analysis II is carried out after 50% of the subjects completed 3 cycles of chemotherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind; Randomized Controlled Trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, at least 18 years old
- •Welfare scale 0, 1, and 2 (ECOG - WHO)
- •Patients with stage IV breast cancer who have histopathological data according to the TNM Classification of Malignant Tumors (TNM) from American Joint Committee on Cancer (AJCC) 8th edition 2017
- •Patients who are willing to participate in the test and sign an informed consent
- •Patients who undergo breast cancer chemotherapy with luminal B sub-type or triple negative with anthracycline base
- •Patients who are willing and able to fill out a questionnaire
- •The patients who are willing and able to comply with the test protocols during the test
排除标准
- •Unable to meet the test protocol
- •Patients with liver and kidney disorders
- •Patients with other diseases/disorders that are meaningful according to the investigators will be excluded from the test
- •Patients with cancer that has metastasized to the brain
- •Pregnant women and breastfeeding mothers
- •Patients with the ejection fraction smaller-than or equal to 55%
研究组 & 干预措施
Placebo
receive a plasebo capsule 2 doses per day
干预措施: Placebo capsule (Other)
FADA 800 mg/day
receive FADA capsules twice a day (each 400 mg)
干预措施: FADA (active fraction of Ficus septica leaf) 800 mg/day (Dietary Supplement)
FADA 2000 mg/day
receive FADA capsules twice a day (each 1000 mg)
干预措施: FADA (active fraction of Ficus septica leaf) 2000 mg/day (Dietary Supplement)
结局指标
主要结局
Quality of life assessment
时间窗: The measurement is at 3-7 days before the 4th cycle of chemotherapy (each cycle is 21 days), and 14-21 days after the 6th cycle (each cycle is 21 days)
The change of quality of life index during 6 cycles of chemotherapy (each cycle is 21 days). The score ranges from 0 (best) to 100 (worst).
次要结局
- Adverse events (AEs) and Serious Adverse Events (SAEs).(throughout the duration of the trial (126 days) or 6 cycles of chemotherapy (each cycle is 21 days))
研究者
Nanang Fakhrudin
Head of Department of Pharmaceutical Biology, Faculty of Pharmacy
Gadjah Mada University