RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy (TCM)

Peking University Cancer Hospital & Institute

Status and phase: Active, not recruiting; Phase 2

Conditions: Cancer-related Problem/Condition

Treatments: Drug: Placebo; Drug: TCM Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT05229029

SF2020-2-1023 (Other Grant/Funding Number)

CHEM FATI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 2 patient groups, including a placebo group

TCM decoction

Experimental group

Description:

Compound granules of Traditional Chinese Medicine

Treatment:

Drug: TCM Formula

placebo

Placebo Comparator group

Description:

Placebo only

Treatment:

Drug: Placebo