Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT06381557
Eligibility Criteria:
Inclusion Criteria:
1. 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.
2. 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.
3. Meets the diagnosis criteria for cancer-related fatigue.
4. Average score on the Brief Fatigue Inventory (BFI) in the 14 days preceding enrollment is ≥4.
5. Life expectancy of at least 6 months.
6. Age between 18 and 70 years old.
7. 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:
1. 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);
2. Presence of severe primary diseases in the cardiovascular, cerebrovascular, immune systems, or requiring treatment for mental illness;
3. Hypokalemia (blood potassium \<3.0mmol/L) or electrolyte imbalance with related symptoms or symptoms that may occur after enrollment;
4. Unimproved hypothyroidism;
5. Hypoalbuminemia (blood albumin \<30g/L) or malnutrition (Body Mass Index, BMI \<18 kg/m²);
6. Traditional Chinese medicine syndrome pattern consistent with Yin deficiency and internal heat;
7. 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);
8. Known allergy to the investigational drug or its components;
9. Breastfeeding, pregnant, or planning to become pregnant within 3 months;
10. The investigator deems the individual unsuitable for participation in this clinical trial.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06381557
Study Brief:
Protocol Section:
NCT06381557