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NCT05229029 Clinical Trial

RSYR for Fatigue Reduction in Cancer Fatigue Caused by Chemotherapy

Cancer-related Problem/Condition Clinical Trial

— TCM  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05229029
Other study ID # CHEM FATI
Secondary ID SF2020-2-1023
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date April 2, 2020
Est. completion date June 30, 2024

Study information
Verified date January 2024
Source Peking University Cancer Hospital & Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 196
Est. completion date June 30, 2024
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TCM 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.
• Placebo
Mainly made of dextrin and caramel, containing 1/30 concentration of experimental group drugs

Locations
Country Name City State
China Beijing Cancer Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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