Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care: A Randomized Controlled Open-label Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change from baseline in FACT-G at week 4
研究概览
简要总结
In this clinical trial we want to investigate the clinical benefit of a complementary therapy using therapeutical modalities of the traditional chinese medicine in patients suffering from advanced cancer.
详细描述
After giving informed consent, the participants will be randomized into two groups (1:1). Both groups will receive standard care while one group will additionally be assigned to a practitioner of traditional Chinese medicine (TCM) who will deliver a individual treatment according to the needs of the participant (pragmatic approach).
Outcome measures will be monitored over the course of eight weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One of the following tumor entities
- •Colorectal cancer (CRC)
- •Lung cancer (SCLC, NSCLC)
- •Breast cancer (BC)
- •Pancreas/Cholangiocellular cancer
- •Best supportive care (i.e., no currently ongoing tumor-specific therapy)
- •o Exception: palliative anti-hormonal therapy or palliative radiotherapy
- •Performance status: ECOG 0 to 2
- •Estimated life expectancy > 4 months
排除标准
- •Any serious concomitant systemic disorder
- •Pregnancy or breast-feeding
- •Impossibility to attend TCM practices in Graz
- •Incapacity to comply/consent
- •Language barrier
- •Brain metastases
结局指标
主要结局
Change from baseline in FACT-G at week 4
时间窗: Baseline and week 4
FACT-G ((Functional Assessment of Cancer Therapy - General) is a validated multi-dimensional quality of life (QoL) questionnaire. It consists of 26 items and addresses four dimensions of QoL, including physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), and social wellbeing (SWB). The scoring system is a five-point Likert scale assessing the QoL of the past seven days. The FACT-G total score has a range of 0-108, whereas higher scores indicate a higher QoL.
次要结局
- Change from baseline in FAMCARE-2 at week 4 and 8(Baseline and week 4 and 8)
- Change from baseline in FACT-G at week 8(Baseline and week 8)
- Change of symptom burden, assessed by ESAS-R(Baseline and weekly until week 8)
- Change in use of Pro re nata medication (P.R.N.M.), assessed by Pro re nata medication diary(Daily from baseline to week 8)
- Change from baseline in PHQ-9 at week 4 and 8(Baseline and week 4 and 8)