Yangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients

Sleep Disorder Clinical Trial

Official title: Yangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients With Qi-Yin Deficiency Syndrome During Chemotherapy: a Multicenter, Randomized, Prospective, Real-world Study

Status Active, not recruiting

Clinical Trial Summary

This is a nationwide, multicenter, randomized, prospective, real-world study. The purpose of this study is to evaluate the effect and safety of Yangzheng Compound Mixture in the treatment of sleep disorder in cancer patients with Qi-Yin deficiency syndrome during chemotherapy.

Clinical Trial Description

Sleep disturbance is one of the most common symptoms in cancer patients, the morbidity is about 60%. Drugs commonly used to treat sleep disorders include benzodiazepines, hypnotic antidepressants and melatonin receptors agonists. The short-term efficacy of these drugs has been proven in many clinical trials, but long-term medications bear the risk of adverse reactions and addiction.

Yangzheng Compound Mixture is an extract of several traditional Chinese medicines, used as a basic prescription for cancer therapy, especially for patients who received chemotherapy with Qi-Yin deficiency syndrome, which often lead to sleep disturbance, fatigue and anorexia. According to some clinical and basic studies, Yangzheng Compound Mixture also has antitumor and immunomodulatory effects.

In this study, about 10 research centers will participate. We planned to enroll 1526 cancer patients (1144 cases in the observation group and 382 cases in the control group) with Qi-Yin deficiency Syndrome and sleep disorders during the period of receiving chemotherapy or combination of chemotherapy. The dynamic random method was adopted in this study, participants will be randomly divided into the experimental group (Yangzheng Compound Mixture plus conventional treatment) and control group (conventional treatment only), all of them will be interviewed once every 3 weeks until the end of the study. ;

Related Conditions & MeSH terms

• Carcinoma
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

• NCT number: NCT04641819
• Study type: Interventional
• Source: ShuGuang Hospital
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: April 27, 2021
• Completion date: June 30, 2024