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| ID | Type | Description | Link |
|---|---|---|---|
| SF2020-2-1023 | Other Grant/Funding Number | Beijing Science and Technology Commission |
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This is a multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of Chinese herbal compound in improving fatigue symptoms and quality of life in patients with chemotherapy.
In this study, symptomatic indicators and quality of life were used as the main evaluation indicators. Patients with moderate to severe CRF who received dual drug chemotherapy were given traditional Chinese medicine compound and placebo intervention respectively. The data of fatigue symptoms, quality of life, sleep quality, blood routine test, liver and kidney function were observed and compared, so as to verify the traditional Chinese medicine compound prescription in improving the CRF symptoms and quality of life of chemotherapy patients validity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM decoction | Experimental | Compound granules of Traditional Chinese Medicine |
|
| placebo | Placebo Comparator | Placebo only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCM Formula | Drug | TCM herbs:White peony 10g, angelica 10g, Astragalus 20g, Atractylodes macrocephala 10g, tangerine peel 6g, Poria cocos 10g, raw land 10g, cinnamon 3g, Polygala tenuifolia 6g, Schisandra chinensis 6g, raw licorice 6g. |
| 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. | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Sun | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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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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| Placebo | Drug | Mainly made of dextrin and caramel, containing 1/30 concentration of experimental group drugs |
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