Cancer-related Problem/Condition
Conditions
Keywords
Chemotherapy, Fatigue, Cancer
Brief summary
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
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.
Interventions
DRUGTCM Formula
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.
DRUGPlacebo
Mainly made of dextrin and caramel, containing 1/30 concentration of experimental group drugs
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue score | 21 days | 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. |
Countries
China
Outcome results
None listed