Clinical trial NCT06381557: Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cancer-related Fatigue
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Yangtze River Pharmaceutical Group Co., Ltd.
First posted: 2024-04-24
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 \&amp;amp;amp;lt;60 mL/min/1.73m²) or abnormalities in the hematological system (platelet count \&amp;amp;amp;lt;75×10⁹/L, hemoglobin \&amp;amp;amp;lt;100g/L, or neutrophil count \&amp;amp;amp;lt;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 \&amp;amp;amp;lt;3.0mmol/L) or electrolyte imbalance with related symptoms or symptoms that may occur after enrollment;
4. Unimproved hypothyroidism;
5. Hypoalbuminemia (blood albumin \&amp;amp;amp;lt;30g/L) or malnutrition (Body Mass Index, BMI \&amp;amp;amp;lt;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.

Primary outcomes:
measure: Fatigue degree with the Brief Fatigue Inventory（BFI）
timeFrame: 8 weeks
Secondary outcomes:
measure: Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R）
timeFrame: 8 weeks
measure: Fatigue degree with the MD Anderson Symptom Inventory（MDASI）
timeFrame: 8 weeks
measure: Change of patients' functional status with Karnofsky performance status (KPS)
timeFrame: 8 weeks
measure: Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23）
timeFrame: 8 weeks
Other outcomes:
measure: Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively
timeFrame: 8 weeks
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Study officials:
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