RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter, Randomized, Double-blind Clinical Trial of TCM in Reducing CRF Caused by Chemotherapy in Cancer Patients

Conditions
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Cancer-related Problem/Condition

Intervention / Treatment
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* Drug: TCM Formula
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malignant tumor patients with pathological diagnosis Men and women aged 18-75 KPS score ≥ 70, expected survival time more than 6 months The function of heart, lung, liver and kidney was normal Hemoglobin ≥ 8g Neuroendocrine function is normal BMI ≥ 18.5. Cancer pain, VAS score < 3 Fatigue score ≥ 4 syndrome differentiation is deficiency of Qi and blood Exclusion Criteria: Brain metastases with Symptomatic Mental disease Severe infection Insomniacs Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM decoction<br>Compound granules of Traditional Chinese Medicine | Drug: TCM Formula<br>* 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.<br>|
| Placebo Comparator: placebo<br>Placebo only | Drug: Placebo<br>* Placebo made of dextrin and caramel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Fatigue, Cancer