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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,127
At the end of the treatment period, the investigator can decide whether to continue the medication based on the improvement of the subjects' sleep disturbance. Medication during the follow-up period: subjects will enter the follow-up period after completing one course of Yangzheng Compound Mixture treatment or the end of the treatment period. Visits will be conducted once every 3 weeks, at least 2 times and no more than 4 times. For subjects in the experimental group, doctors can decide whether the patients should continue to receive Yangzheng Compound Mixture therapy in the follow-up period according to the improvement of sleep disorders, while for subjects in the control group, the patients can choose to start receiving Yangzheng Compound Mixture therapy in the follow-up period according to their own wishes and doctors' suggestions.
Including treatment of sleep disorders and tumor which shall follow the clinical guidelines.
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China
Best effective rate for sleep disorder treatment
Proportion of participants with a minimum PSQI score \< 8 during the treatment period.
Time frame: Measurement was taken at week 6.
Effective rate for sleep disorder treatment
Proportion of participants with PSQI score \< 8 after the end of the different treatment courses.
Time frame: Measurement was taken at week 6.
Improvement rate for sleep disorder treatment
Proportion of participates whose PSQI score decreased during treatment compared with the baseline.
Time frame: Measurement was taken at week 6.
Change of PSQI score compared with baseline
The PSQI score difference between the end of different treatment courses and baseline.
Time frame: Baseline and week 6.
Score of Pittsburgh Sleep Quality Index (PSQI), Sleep duration, Sleep efficiency, Subjective sleep quality, Sleep latency.
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.
Time frame: Measurement was taken at week 6.
Incidence and severity of AE or SAE
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.
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Henan Cancer Hospital
Zhengzhou, Henan, China
The Second Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
The Third Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Shuguang Hospital Affiliated with Shanghai University of TCM
Shanghai, Shanghai Municipality, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Affiliated Hospital of Shanxi University of Chinese Medicine
Xianyang, Shanxi, China
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China
Time frame: Start of treatment until 30 days after the last day of the sleep disorder treatment
Incidence and severity of ADR or SADR
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.
Time frame: Start of treatment until 30 days after the last day of the sleep disorder treatment
Use frequency of hypnotic agents
Response to question 6 of the PSQI scale.
Time frame: Up to 18 weeks since the start of treatment
Appetite
Appetite was evaluated by using the Cancer Appetite and Symptom Questionnaire(CASQ).
Time frame: Up to 18 weeks since the start of treatment
Fatigue
Fatigue was evaluated by using the Brief Fatigue Inventory(BFI).
Time frame: Up to 18 weeks since the start of treatment
Quality of life (QOL)
Quality of Life (QOL) was measured by using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Time frame: Up to 18 weeks since the start of treatment
Traditional Chinese Medical symptoms scale
Traditional Chinese Medical (TCM) symptoms were measured from these six aspects: weakness, shortness of breath, palpitations, deficiency-heat and vexation, dry mouth, sweat. The minimum score is 0 and the maximum value is 18. Higher scores of TCM scale means a worse outcome.
Time frame: Up to 18 weeks since the start of treatment