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
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,127
- 试验地点
- 10
- 主要终点
- Change of PSQI score compared with baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Yangzheng Compound Mixture plus conventional treatment
Yangzheng Compound Mixture: 10mL, 2 doses each time, 3 times a day, three weeks for a course of treatment. Investigators recommended that the participants of experimental group should use Yangzheng Compound Mixture for 2 courses at least.
Conventional treatment:
Antitumor therapies: chemotherapy or combined chemotherapy. Sleep disorders: includes but is not limited to pharmacotherapy and exercise therapy.
The examination, diagnosis and treatment of other concomitant diseases and tumor complications are based on clinical routine. We will collect information about all the combined medicine.
干预措施: Yangzheng Compound Mixture (Drug)
Yangzheng Compound Mixture plus conventional treatment
Yangzheng Compound Mixture: 10mL, 2 doses each time, 3 times a day, three weeks for a course of treatment. Investigators recommended that the participants of experimental group should use Yangzheng Compound Mixture for 2 courses at least.
Conventional treatment:
Antitumor therapies: chemotherapy or combined chemotherapy. Sleep disorders: includes but is not limited to pharmacotherapy and exercise therapy.
The examination, diagnosis and treatment of other concomitant diseases and tumor complications are based on clinical routine. We will collect information about all the combined medicine.
干预措施: Conventional Treatment (Other)
conventional treatment only
Antitumor therapies: chemotherapy or combined chemotherapy. Sleep disorders: includes but is not limited to pharmacotherapy and exercise therapy.
The examination, diagnosis and treatment of other concomitant diseases and tumor complications are based on clinical routine. We will collect information about all the combined medicine.
干预措施: Conventional Treatment (Other)
结局指标
主要结局
Change of PSQI score compared with baseline
时间窗: Baseline and week 6.
The PSQI score difference between the end of different treatment courses and baseline.
Best effective rate for sleep disorder treatment
时间窗: Measurement was taken at week 6.
Proportion of participants with a minimum PSQI score \< 8 during the treatment period.
Score of Pittsburgh Sleep Quality Index (PSQI), Sleep duration, Sleep efficiency, Subjective sleep quality, Sleep latency.
时间窗: Measurement was taken at week 6.
1. The outcomes were evaluated using the PSQI scale. 2. Sleep duration: response to question 4; 3. Sleep efficiency= (hours slept/ hours in bed) \* 100%; Hours slept: response to question 4; Hours in bed: calculated from responses to questions 1 and 3; 4. Subjective sleep quality: response to question 9; 5. Sleep latency: response to question 2.
Improvement rate for sleep disorder treatment
时间窗: Measurement was taken at week 6.
Proportion of participates whose PSQI score decreased during treatment compared with the baseline.
Incidence and severity of AE or SAE
时间窗: Start of treatment until 30 days after the last day of the sleep disorder treatment
AE: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAE: A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Effective rate for sleep disorder treatment
时间窗: Measurement was taken at week 6.
Proportion of participants with PSQI score \< 8 after the end of the different treatment courses.
Incidence and severity of ADR or SADR
时间窗: Start of treatment until 30 days after the last day of the sleep disorder treatment
All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. A SADR is a serious ADR according to the above criteria of SAE.
次要结局
- Use frequency of hypnotic agents(Up to 18 weeks since the start of treatment)
- Appetite(Up to 18 weeks since the start of treatment)
- Fatigue(Up to 18 weeks since the start of treatment)
- Quality of life (QOL)(Up to 18 weeks since the start of treatment)
- Traditional Chinese Medical symptoms scale(Up to 18 weeks since the start of treatment)
研究者
Qi Li
Professor
ShuGuang Hospital