Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules
ConditionCancer-related Fatigue
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorQiang Fu
About this trial
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.
Eligibility criteria
Qualifiers
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 ≥4.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Zhengyuan Capsules
- Placebo contains 5%-10% Zhengyuan Capsule total mixed powder
Treatment groups
240 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Qiang Fu
Lead sponsor
Tongji Hospital
Sponsor institution
Yangtze River Pharmaceutical Group Co., Ltd.
Collaborator
Source ClinicalTrials.gov