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

Inclusion Criteria:

• Age ≥18;

• Histologically or cytologically confirmed as malignant tumor;

• Receiving chemotherapy or a combination of chemotherapy;

• The syndrome differentiation of traditional Chinese medicine is the Qi-yindeficiency syndrome;

• Sleep disorders were diagnosed by investigators and the Pittsburgh Sleep QualityIndex (PSQI) score was ≥ 8;

• The date of diagnosis of sleep disorder is later than the date of the firstdiagnosis of cancer. Or patients with sleep disorders for a long time receivingregular treatment，sleep disorders aggravated after cancer diagnosis or chemotherapy;

• Pain has been controlled well [patients were being treated with analgesicsregularly，numerical rating scale（NRS） score ≤ 3];

• The participant must be able to read and express themselves clearly, can communicatewith investigators and cooperate in completing the questionnaire;

• Participants voluntarily join the study with good compliance, and are willing tosign a written informed consent document;

• Survival period will be longer than 6 months.

Exclusion Criteria:

• Pregnant or lactating women;

• Allergic to Yangzheng Compound Mixture;

• Previous diagnosis of sleep apnea;

• The laboratory test value of liver and renal function is more than 2.5 times theupper limit of normal value;

• Symptoms of brain metastasis due to malignant tumor has not been effectivelycontrolled;

• Participating in other drug clinical trials which did not allow to participate inthis study;

• Refused to cooperate with follow-up;

• The researchers did not consider it appropriate for the patients to participate inthis study for other reasons.