NCT06381557

Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study on the Effectiveness and Safety of Zhengyuan Capsules for Cancer-related Fatigue in Patients With Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Qiang Fu · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer.

Detailed description

By conducting multi-center, randomized, double-blind, placebo-controlled clinical research to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer.This test choose the improvement of fatigue degree as key indicator, and choose the improvement both symptoms of patients and quality of life as second indicators. And last, the study will try to verify its safety and efficacy with some haematological indexs and reveal its mechanism from the perspectives of Cytokines and immunological indicators, so as to explore the advantages of traditional Chinese medicine（TCM） in the treatment of CRF and support some high quality, internationally recognized clinical evidence.

Conditions

• Cancer-related Fatigue

Interventions

Type	Name	Description
DRUG	Zhengyuan Capsules	Zhengyuan capsules, 4 capsules at a time, 3 times per day;
DRUG	Placebo contains 5%-10% Zhengyuan Capsule total mixed powder	Zhengyuan capsules simulator（Placebo contains 5%-10% Zhengyuan Capsule total mixed powder）, 4 capsules at a time, 3 times per day;

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-04-24
• Last updated: 2024-04-24