The Study on the Clinical Value of Fufang E'Jiao Jiang Intervening Cancer-related Fatigue (Deficiency of Qi and Blood)
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Fatigue degree with the Piper fatigue scale (Piper)
研究概览
简要总结
With the therapeutic tool of carcinoma increasing, life span extending, the solicitude for the patients'quality of life appear more important. Cancer-related fatigue (CRF) is one of the most prevalent and debilitating symptoms experienced by people with cancer. It can persist for months or years after cancer therapy is completed and has a negative impact on all areas of function. Meaningful evidence-based treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Our previous clinical experience have shown that traditional Chinese medicine（TCM） had a great effect on improving CRF, Several studies proven that its'mechanism were related to the regulation of immune function and endocrine hormones. Fufang E'Jiao Jiang (FFEJJICRF) is a commonly-used Chinese patent medicine and successfully marketed in China for many years, which are effective in improvement for TCM symptoms of deficiency with qi and blood. This proposal will investigate the effects of FFEJJICRF on CRF among non-small cell lung cancer, colorectal cancer, and gastric cancer, so as to find a new way for curing it in clinical.
详细描述
By conducting large sample, multicenter, double-blind, randomized comparison clinical research, this test will investigate the effects of fufang E'Jiao Jiang intervening cancer-related fatigue (CRF) with deficiency of qi and blood, under the guidance of its specification. This test choose the improvement of fatigue degree as key indicator, and choose the improvement both symptoms of patients and quality of life as second indicators. And last, the study will try to verify its safety and efficacy with some haematological indexs and reveal its mechanism from the perspectives of hormone, immune and metabonomics, so as to explore the advantages of traditional Chinese medicine（TCM） in the treatment of CRF and support some high quality, internationally recognized clinical evidence.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of patients between 18 and 75，gender not limited.
- •Patients that pathologically diagnosed with colorectal cancer, non-small cell lung cancer (NSCLC) or gastric cancer.
- •The patients' TNM stage of NSCLC is IIIB-IV, colorectal cancer is IV, and gastric cancer is IV, in addition all of them should be with tumors that can not be radically resected.
- •If patients have not received chemotherapy, they should be evaluated that tumor will not progress within 30 days, and their bodies can tolerate intravenous targeted therapy.
- •Patients who meet the diagnostic criterion for cancer related fatigue with deficiency of qi and blood.
- •The expected survival period is more than 3 months.
- •Fatigue score evaluated by visual analogue fatigue scale isn't lower than 4, and Karnofsky scale score isn't lower than
- •Good compliance and agreeable to sign an informed consent before test.
- •Subjects agree not to participate in other intervention studies during test.
排除标准
- •Those who need immunotherapy or radiotherapy during the test.
- •Those who have significant trauma injuries in the past one month.
- •Those who have severe bleeding or systemic infection diseases that had not been completely controlled.
- •Those who have tangible proofs of marrow or central nervous system metastasis.
- •Those who have received erythropoietin or blood transfusion within 1 month before test.
- •Those who have hypersplenism, hyperthyroidism, desmosis, tuberculosis and other diseases that have not been completely controlled.
- •Those who complicated with serious diseases such as cardiovascular or cerebrovascular system diseases, active hepatitis, disfunction of liver or kidney.
- •Those who are known or suspected to be allergic to test drugs.
- •Those who have eaten EJiao products in the past 2 weeks.
- •Those who have occurred Ileus.
- •Those suffering from severe malabsorption or other diseases that affect gastrointestinal absorption.
- •Those who cannot understand, read and fill in the self-rating scale due to their level of knowledge or intelligence.
- •Those who may happen any unstable conditions or conditions that endanger the patient's safety or compliance, for example the spirits.
- •Those who have been diagnosed with other malignant tumors (except fully treated cervix and skin carcinoma in situ, or other tumors that have been surgically cured and not recurred for at least 5 years) .
- •Those who participated in other therapeutic clinical trials within 30 days.
- •Pregnant or nursing women, or childbearing female that are inadequate contraception.
- •Those who are inappropriate to participate in the study determined by investigators.
研究组 & 干预措施
Treatment group
Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21days each cycle, and use 2 cycles
干预措施: Fufang E'Jiao Jiang (Drug)
control group
Placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
干预措施: placebo containing low-dose fufang E'Jiao Jiang (Drug)
结局指标
主要结局
Fatigue degree with the Piper fatigue scale (Piper)
时间窗: 6 weeks
Piper is composed of 24 questions assessing total CRF, as well as subscales of behavioral, affective, sensory, and cognitive/mood fatigue. Each question is cored from 0 to10 points, where a higher score indicates severe symptoms; 1 to 3 point is mild, 4 to 6 point is moderate, and 7 to 10 point is severe. Piper is taken at the baseline, 1 weeks, 3 weeks,4 weeks, and 6 weeks after treatment
次要结局
- Change from baseline in T-cells Subsets Counts up to 6 Weeks: T-Cells Subsets(6 weeks)
- Aldosterone, insulin-like growth factor, cortisol, growth hormone(6 weeks)
- Change from baseline in lymphocyte subsets counts up to 6 Weeks: T Cell, B Cell, Natural Killer Cell (T,B,NK)(6 weeks)
- The occurrence of myelosuppression during chemotherapy(10 weeks)
- The amounts of leukocyte cells, hemoglobin and platelet in peripheral blood(10 weeks)
- Change of patients' living quality with the Edmonton symptom assessment scale(ESAS)(10 weeks)
- Change of patients' functional status with Karnofsky performance status (KPS)(10 weeks)
- Quality of Life with Functional assessment of cancer therapy-fatigue（FACT-F）(6 weeks)
- T-Cell Cytokines(6 weeks)
- Circulating metabolite concentrations by nontargeted metabolomics techniques(6 weeks)
- Triiodothyronine, free triiodothyronine, bound thyroxine, free thyroxine, thyroid stimulating hormone(6 weeks)