Pilot Observational Study and Safety Analysis of FL Nourish Capsules in Cancer Patients in Remission
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pre-post values of EORTC QLQ-C30 questionnaire test scores
研究概览
简要总结
This is a single-centre, observational prospective study of cancer patients in remission administering FL Nourish capsules (FLNC), a proprietary Chinese Medicine herbal supplement, for the treatment of symptoms associated with qi deficiency and blood stasis syndrome.
详细描述
Consultation data will be analysed from up to 24 cancer patients in remission receiving routine treatment at Singapore Thong Chai Medical Institution. Each participant will visit the institution in accordance with the protocol which includes up to 9 months of FL Nourish capsule (FLNC) use and up to 8 consultation visits. Participants will be evaluated based on consultation data, questionnaire data, routine blood test data and self-reporting of adverse events or severe adverse events. As this is a non-interventional observational study, all participants would have received FLNC prescriptions according to routine diagnostic and prescribing standards, and there were no additional visits required aside from routine follow up consultations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21-80;
- •Cancer diagnosis ≤ 5 years;
- •Received treatment with no current evidence of recurrence, with predicted life expectancy of 12 months and above;
- •On regular follow-up with lab tests scheduled every 1-9 months;
- •Recent (<=3 months) blood test report(s) available on first study visit
- •Diagnosed with the TCM syndrome of Qi deficiency and Blood stasis by the primary physician: experience 2 major symptoms coupled with typical tongue and pulse conditions; 2 major symptoms and 1 possible symptom coupled with tongue and pulse conditions; and 1 major symptom and at least 2 possible symptoms coupled with tongue and pulse conditions;
排除标准
- •On active cancer treatment such as IV chemotherapy or radiotherapy or oral targeted therapy (excluding HRT and oral chemotherapy);
- •Scheduled for IV chemotherapy, radiotherapy or surgery within the next 1 year from recruitment date;
- •Diagnosed with active disease of the liver, kidney, brain, blood, blood vessels; with mental health conditions or are mentally incapacitated;
- •Pregnant women.
结局指标
主要结局
Pre-post values of EORTC QLQ-C30 questionnaire test scores
时间窗: From enrollment to the end of treatment at 10 months
0 is equivalent to a low QoL/functioning/symptom score and 100 indicates the best posssible QoL/functioning/symptom score.
次要结局
- Incidence of unanticipated adverse events or severe adverse events: estimated to be <= 10%(From enrollment to the end of treatment at 10 months)
- Pre-post values of Alanine aminotransferase (ALT)(From enrollment to the end of treatment at 10 months)
- Pre-post values of Aspartate aminotransferase (AST)(From enrollment to the end of treatment at 10 months)
- Pre-post values of albumin-to-creatinine ratio (ACR)(From enrollment to the end of treatment at 10 months)