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| ID | Type | Description | Link |
|---|---|---|---|
| PZ2017019 | Other Grant/Funding Number | Beijing Municipal Hospital Administration Training Program |
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This randomized Phase II trial to establish the efficacy of traditional Chinese medicine (TCM) herbal products above control group for treating fatigue in patients with cancer.
Patients who were randomized and been enrolled in, had stable disease and no anemia, and reported moderate to severe fatigue over two months (rated ≥4 on a 0-10 scale). Patients took TCM decoction Renshen Yangrong decoction (RSYR),Which containing 12 TCM herbs, twice a day for 6 weeks. RSYRT aims to correct Qi deficiency. Fatigue was assessed before and after RSYRT therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSYYT decoction | Experimental | RSYYT decoction Compound granules of traditional Chinese medicine |
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| Astragalus membranaceus | Experimental | one herb decoction Compound granules of one herb (Astragalus membranaceus) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSYRT decoction | Drug | Compound granules of traditional Chinese medicine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue score | Self-assessed 24-hour fatigue symptom score. According to the NCCN fatigue guide, the score is 0-10 points, 0 points means no fatigue, 10 points means the most serious fatigue that can be imagined. | 6 weeks |
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Inclusion Criteria:
Pathological diagnosis of malignant tumors; 3 months without surgery, radiotherapy and chemotherapy, biological treatment; Hemoglobin > 11g/L; Complete remission of the lesion, or recent review of the Disease is stable, the estimated survival time is more than 6 months; ECOG score is 0-2, fatigue score of the last 24 hours > 4 ; Age is 18-65 years old; TCM syndrome differentiation for deficiency of qi; Liver, kidney function, electrolyte normal; Willing to join the group and sign the informed consent.
Exclusion Criteria:
Allergies to herbs and plant drugs; Uncontrollable diabetes, hypertension, TSH abnormalities, uncontrollable pain, and a history of myocardial infarction within 6 months; Scores of anxiety disorders and depression (HAD-D) were 11 or more, antidepressants and antioxidants were used in the past month; Breast cancer receptor positive patients took endocrine therapy drugs; Tonics were used in the past 2 weeks.; Children, pregnant and lactating women; Receiving anemia-related treatment; Chinese medicine syndrome differentiation with excessive heat; Unable to read or understand the scale.
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| Name | Affiliation | Role |
|---|---|---|
| Pingping Li, Prof. | Peking University Cancer Hospital & Institute | Study Director |
| Ting Lu, Dr. | Peking University Cancer Hospital & Institute | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31668965 | Derived | Xu Y, Wang XS, Chen Y, Shi Q, Chen TH, Li P. A Phase II Randomized Controlled Trial of Renshen Yangrong Tang Herbal Extract Granules for Fatigue Reduction in Cancer Survivors. J Pain Symptom Manage. 2020 May;59(5):966-973. doi: 10.1016/j.jpainsymman.2019.10.018. Epub 2019 Oct 24. |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C027492 | Huang Qi |
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a randomized Phase II trial
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| Astragalus membranaceus |
| Drug |
One herb |
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