Clinical trial NCT04641819: Yangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Carcinoma
Sleep Disorder
Keywords: Yangzheng Compound Mixture
Carcinoma
Sleep Disorder
Lead sponsor: ShuGuang Hospital
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
name: Shaanxi Buchang Pharmaceutical Co., Ltd
First posted: 2020-11-24
Enrollment: 1127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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-yin deficiency syndrome;
* Sleep disorders were diagnosed by investigators and the Pittsburgh Sleep Quality Index (PSQI) score was ≥ 8;
* The date of diagnosis of sleep disorder is later than the date of the first diagnosis of cancer. Or patients with sleep disorders for a long time receiving regular treatment，sleep disorders aggravated after cancer diagnosis or chemotherapy;
* Pain has been controlled well \[patients were being treated with analgesics regularly，numerical rating scale（NRS） score ≤ 3\];
* The participant must be able to read and express themselves clearly, can communicate with investigators and cooperate in completing the questionnaire;
* Participants voluntarily join the study with good compliance, and are willing to sign 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 the upper limit of normal value;
* Symptoms of brain metastasis due to malignant tumor has not been effectively controlled;
* Participating in other drug clinical trials which did not allow to participate in this study;
* Refused to cooperate with follow-up;
* The researchers did not consider it appropriate for the patients to participate in this study for other reasons.

Primary outcomes:
measure: Best effective rate for sleep disorder treatment
timeFrame: Measurement was taken at week 6.
measure: Effective rate for sleep disorder treatment
timeFrame: Measurement was taken at week 6.
measure: Improvement rate for sleep disorder treatment
timeFrame: Measurement was taken at week 6.
measure: Change of PSQI score compared with baseline
timeFrame: Baseline and week 6.
measure: Score of Pittsburgh Sleep Quality Index (PSQI), Sleep duration, Sleep efficiency, Subjective sleep quality, Sleep latency.
timeFrame: Measurement was taken at week 6.
measure: Incidence and severity of AE or SAE
timeFrame: Start of treatment until 30 days after the last day of the sleep disorder treatment
measure: Incidence and severity of ADR or SADR
timeFrame: Start of treatment until 30 days after the last day of the sleep disorder treatment
Secondary outcomes:
measure: Use frequency of hypnotic agents
timeFrame: Up to 18 weeks since the start of treatment
measure: Appetite
timeFrame: Up to 18 weeks since the start of treatment
measure: Fatigue
timeFrame: Up to 18 weeks since the start of treatment
measure: Quality of life (QOL)
timeFrame: Up to 18 weeks since the start of treatment
measure: Traditional Chinese Medical symptoms scale
timeFrame: Up to 18 weeks since the start of treatment
Other outcomes:
measure: Proportion of leukocyte-increasing drugs used
timeFrame: Up to 18 weeks since the start of treatment
Locations:
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Ha'erbin
country: China
facility: First Affiliated Hospital, Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Jiamusi
country: China
facility: Jiamusi Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: The Second Affiliated Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Jinan
country: China
facility: The Third Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Shanghai
country: China
facility: Shuguang Hospital Affiliated with Shanghai University of TCM
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Xianyang
country: China
facility: Affiliated Hospital of Shanxi University of Chinese Medicine
state: Shanxi
city: Hangzhou
country: China
facility: Cancer Hospital of The University of Chinese Academy of Sciences
state: Zhejiang
Study officials:
affiliation: Shuguang Hospital Affiliated with Shanghai University of TCM
name: Qi Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: