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
Overview
- Phase
- Phase 4
- Intervention
- Zhengyuan Capsules
- Conditions
- Cancer-related Fatigue
- Sponsor
- Qiang Fu
- Enrollment
- 240
- Primary Endpoint
- Fatigue degree with the Brief Fatigue Inventory（BFI）
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Qiang Fu
Professor
Tongji Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Experimental Group
Intervention: Zhengyuan Capsules
Control Group
Intervention: Placebo contains 5%-10% Zhengyuan Capsule total mixed powder
Outcomes
Primary Outcomes
Fatigue degree with the Brief Fatigue Inventory（BFI）
Time Frame: 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.
Secondary Outcomes
- 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)