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| Name | Class |
|---|---|
| Yangtze River Pharmaceutical Group Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental |
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| Control Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zhengyuan Capsules | Drug | Zhengyuan capsules, 4 capsules at a time, 3 times per day; |
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| Measure | Description | Time Frame |
|---|---|---|
| Fatigue degree with the Brief Fatigue Inventory（BFI） | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R） | PFS-R is derived from the Piper Fatigue Scale by reducing the number of items. It includes 22 items assessing behavior, emotion, sensation, and cognition. Each question is cored from 0 to10 points, where a higher score indicates severe symptoms; 1 to 3 point is mild, 4 to 6 point is moderate, and 7 to 10 point is severe. , resulting in a total fatigue score ranging from 0 to 220. The average score is calculated by dividing the total score by 22. A higher score indicates greater fatigue.Treatment follow-up: Subjects are required to visit the clinic for Visit 3 (4 weeks ± 3 days after medication) and Visit 5 (8 weeks ± 3 days after medication). For Visit 1 (1 week ± 1 day after medication), Visit 2 (2 weeks ± 1 day after medication), and Visit 4 (6 weeks ± 1 day after medication), researchers will conduct follow-up via telephone to assess the subject's condition, encourage, and assist in completing the assessment and recording of the PFS-R scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively | Safety evaluation，For Visit 3 (4 weeks ± 3 days after medication), it is mandated to perform the specified examinations. The absence of these tests does constitute a deviation from the protocol. If patients undergo relevant examinations during the course of diagnosis and treatment, the data will be collected. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiying Yu, MD. | Contact | +86 13871382805 | syyu@tjh.tjmu.edu.cn |
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| Placebo contains 5%-10% Zhengyuan Capsule total mixed powder | Drug | Zhengyuan capsules simulator（Placebo contains 5%-10% Zhengyuan Capsule total mixed powder）, 4 capsules at a time, 3 times per day; |
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| 8 weeks |
| Fatigue degree with the MD Anderson Symptom Inventory（MDASI） | MDASI is used to assess various symptoms and discomfort experienced by cancer patients during their treatment. Each question is cored from 0 to10 points, where 0 indicates no symptoms or symptoms without interference, and 10 indicates symptoms reaching the most severe imaginable level and causing severe interference. A higher total score indicates more severe symptoms and higher distress from symptoms.Treatment follow-up: Subjects are required to visit the clinic for Visit 3 (4 weeks ± 3 days after medication) and Visit 5 (8 weeks ± 3 days after medication). For Visit 1 (1 week ± 1 day after medication), Visit 2 (2 weeks ± 1 day after medication), and Visit 4 (6 weeks ± 1 day after medication), researchers will conduct follow-up via telephone to assess the subject's condition, encourage, and assist in completing the assessment and recording of the MDASI scale. | 8 weeks |
| Change of patients' functional status with Karnofsky performance status (KPS) | KPS Scores ranged from 100 to 0,The higher score represent the better health, the more likely that you are able to tolerate the side effects of treatment. It is generally considered that Karnofsky80 score or above represent patients can live independently, 60~80 score represent semi-independently, Under 60 represent patients often need help in living.KPS scores should be measured at the baseline, 4 weeks, 8 weeks. | 8 weeks |
| Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23） | The EORTC QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.Each question is cored from 0 to 4points, where 0 indicates no symptoms or symptoms without interference, and 4 indicates symptoms reaching the most severe imaginable level and causing severe interference. QLQ-BR23 were recorded at the baseline and 8 weeks. | 8 weeks |
| 8 weeks |