A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study on the Effectiveness and Safety of Zhengyuan Capsules for Cancer-related Fatigue in Patients With Breast Cancer
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- Fatigue degree with the Brief Fatigue Inventory（BFI）
研究概览
简要总结
Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer.
详细描述
By conducting multi-center, randomized, double-blind, placebo-controlled clinical research to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer.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 Cytokines and immunological indicators, 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histopathologically or cytologically confirmed as breast cancer; AJCC 8th edition staging for breast cancer is stages I to III, clinically and radiologically confirmed with no tumor recurrence or metastasis.
- •Completed anti-tumor treatment (surgery, radiotherapy, chemotherapy, targeted therapy) for at least 2 months, with no planned anti-tumor treatment during the study period, excluding endocrine therapy.
- •Meets the diagnosis criteria for cancer-related fatigue.
- •Average score on the Brief Fatigue Inventory (BFI) in the 14 days preceding enrollment is ≥
- •Life expectancy of at least 6 months.
- •Age between 18 and 70 years old.
- •Patients and their families understand the basic details of the study, agree to cooperate in completing the relevant research; the patient can communicate verbally and in writing; voluntary signing of the informed consent form.
排除标准
- •Presence of significant liver or kidney dysfunction (e.g., alanine transaminase, aspartate transaminase greater than 3 times the upper limit of normal, blood creatinine greater than 1.5 times the upper limit of normal, eGFR <60 mL/min/1.73m²) or abnormalities in the hematological system (platelet count <75×10⁹/L, hemoglobin <100g/L, or neutrophil count <1.5×10⁹/L);
- •Presence of severe primary diseases in the cardiovascular, cerebrovascular, immune systems, or requiring treatment for mental illness;
- •Hypokalemia (blood potassium <3.0mmol/L) or electrolyte imbalance with related symptoms or symptoms that may occur after enrollment;
- •Unimproved hypothyroidism;
- •Hypoalbuminemia (blood albumin <30g/L) or malnutrition (Body Mass Index, BMI <18 kg/m²);
- •Traditional Chinese medicine syndrome pattern consistent with Yin deficiency and internal heat;
- •Use of medications indicated in the instructions or with main functions that meet the following conditions: other Western or Chinese medicine preparations that affect the efficacy evaluation of cancer-related fatigue; undergoing treatment with anti-anemia, anti-anxiety/depression, anti-insomnia, or other psychostimulant drugs; use of drugs with leukocyte-increasing effects within the past week, such as granulocyte colony-stimulating factor (G-CSF);
- •Known allergy to the investigational drug or its components;
- •Breastfeeding, pregnant, or planning to become pregnant within 3 months;
- •The investigator deems the individual unsuitable for participation in this clinical trial.
研究组 & 干预措施
Experimental Group
干预措施: Zhengyuan Capsules (Drug)
Control Group
干预措施: Placebo contains 5%-10% Zhengyuan Capsule total mixed powder (Drug)
结局指标
主要结局
Fatigue degree with the Brief Fatigue Inventory（BFI）
时间窗: 8 weeks
BFI consists of 9 items, each rated from 0 to 10, with fatigue score calculated as the total score divided by 9. A higher score indicates a greater level of fatigue; where 0 indicates no fatigue, 1-3 indicates mild fatigue, 4-6 indicates moderate fatigue, 7-9 indicates severe fatigue, and 10 indicates the most severe fatigue imaginable.In the screening phase, the subjects' fatigue status is assessed using the Brief Fatigue Inventory (BFI). Subjects are required to complete the BFI assessment at a specified time each day for 14 consecutive days and record the assessment results. The Investigators determine the eligibility of subjects based on the average BFI scores over the 14 days, with subjects considered eligible if the BFI average is ≥4 points. During the treatment phase, subjects undergo BFI assessments once a week at specified times (i.e., week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8,) to evaluate their fatigue status.
次要结局
- Fatigue degree with the MD Anderson Symptom Inventory（MDASI）(8 weeks)
- Change of patients' functional status with Karnofsky performance status (KPS)(8 weeks)
- Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23）(8 weeks)
- Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R）(8 weeks)
研究者
Qiang Fu
Professor
Tongji Hospital