Back to resultsYangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients
Primary Purpose
Carcinoma, Sleep Disorder
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Yangzheng Compound Mixture
Conventional Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma focused on measuring Yangzheng Compound Mixture, Carcinoma, Sleep Disorder
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.
Sites / Locations
- Chongqing University Cancer HospitalRecruiting
- First Affiliated Hospital, Heilongjiang University of Chinese MedicineRecruiting
- Jiamusi Cancer HospitalRecruiting
- Henan Cancer HospitalRecruiting
- The Second Affiliated Hospital of Hunan University of Chinese MedicineRecruiting
- The Third Affiliated Hospital of Shandong First Medical UniversityRecruiting
- Shuguang Hospital Affiliated with Shanghai University of TCM
- Zhongshan HospitalRecruiting
- Affiliated Hospital of Shanxi University of Chinese MedicineRecruiting
- Cancer Hospital of The University of Chinese Academy of SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Yangzheng Compound Mixture plus conventional treatment
conventional treatment only
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Best effective rate for sleep disorder treatment
Proportion of participants with a minimum PSQI score < 8 during the treatment period.
Effective rate for sleep disorder treatment
Proportion of participants with PSQI score < 8 after the end of the different treatment courses.
Improvement rate for sleep disorder treatment
Proportion of participates whose PSQI score decreased during treatment compared with the baseline.
Change of PSQI score compared with baseline
The PSQI score difference between the end of different treatment courses and baseline.
Score of Pittsburgh Sleep Quality Index (PSQI), Sleep duration, Sleep efficiency, Subjective sleep quality, Sleep latency.
The outcomes were evaluated using the PSQI scale.
Sleep duration: response to question 4;
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;
Subjective sleep quality: response to question 9;
Sleep latency: response to question 2.
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.
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.
Secondary Outcome Measures
Use frequency of hypnotic agents
Response to question 6 of the PSQI scale.
Appetite
Appetite was evaluated by using the Cancer Appetite and Symptom Questionnaire(CASQ).
Fatigue
Fatigue was evaluated by using the Brief Fatigue Inventory(BFI).
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).
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.
Full Information
NCT ID
NCT04641819
First Posted
November 6, 2020
Last Updated
May 15, 2023
Sponsor
ShuGuang Hospital
Collaborators
LinkDoc Technology (Beijing) Co. Ltd., Shaanxi Buchang Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04641819
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ShuGuang Hospital
Collaborators
LinkDoc Technology (Beijing) Co. Ltd., Shaanxi Buchang Pharmaceutical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Sleep Disorder
Keywords
Yangzheng Compound Mixture, Carcinoma, Sleep Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1525 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yangzheng Compound Mixture plus conventional treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional treatment only
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Yangzheng Compound Mixture
Other Intervention Name(s)
Z10970042（NMPA Approval Number）
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
Including treatment of sleep disorders and tumor which shall follow the clinical guidelines.
Primary Outcome Measure Information:
Title
Best effective rate for sleep disorder treatment
Description
Proportion of participants with a minimum PSQI score < 8 during the treatment period.
Time Frame
Measurement was taken at week 6.
Title
Effective rate for sleep disorder treatment
Description
Proportion of participants with PSQI score < 8 after the end of the different treatment courses.
Time Frame
Measurement was taken at week 6.
Title
Improvement rate for sleep disorder treatment
Description
Proportion of participates whose PSQI score decreased during treatment compared with the baseline.
Time Frame
Measurement was taken at week 6.
Title
Change of PSQI score compared with baseline
Description
The PSQI score difference between the end of different treatment courses and baseline.
Time Frame
Baseline and week 6.
Title
Score of Pittsburgh Sleep Quality Index (PSQI), Sleep duration, Sleep efficiency, Subjective sleep quality, Sleep latency.
Description
The outcomes were evaluated using the PSQI scale.
Sleep duration: response to question 4;
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;
Subjective sleep quality: response to question 9;
Sleep latency: response to question 2.
Time Frame
Measurement was taken at week 6.
Title
Incidence and severity of AE or SAE
Description
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.
Time Frame
Start of treatment until 30 days after the last day of the sleep disorder treatment
Title
Incidence and severity of ADR or SADR
Description
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
Secondary Outcome Measure Information:
Title
Use frequency of hypnotic agents
Description
Response to question 6 of the PSQI scale.
Time Frame
Up to 18 weeks since the start of treatment
Title
Appetite
Description
Appetite was evaluated by using the Cancer Appetite and Symptom Questionnaire(CASQ).
Time Frame
Up to 18 weeks since the start of treatment
Title
Fatigue
Description
Fatigue was evaluated by using the Brief Fatigue Inventory(BFI).
Time Frame
Up to 18 weeks since the start of treatment
Title
Quality of life (QOL)
Description
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
Title
Traditional Chinese Medical symptoms scale
Description
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
Other Pre-specified Outcome Measures:
Title
Proportion of leukocyte-increasing drugs used
Description
Proportion of participates used leukocyte-increasing medication during the treatment period
Time Frame
Up to 18 weeks since the start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Li, PhD
Phone
+86-13918191899
Email
lzwf@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanyuan Feng, PhD
Phone
+86-13248266010
Email
lzwf@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Li, PhD
Organizational Affiliation
Shuguang Hospital Affiliated with Shanghai University of TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang
Phone
+86-15808066707
Facility Name
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiying Song
Phone
+86-13945698031
Facility Name
Jiamusi Cancer Hospital
City
Jiamusi
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueliang Zhang
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaimin Liu
Facility Name
The Second Affiliated Hospital of Hunan University of Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Cao, PhD
Phone
+86-18873102776
Email
cwfly2008@163.com
First Name & Middle Initial & Last Name & Degree
Ling Fu
Phone
+86-15173136845
Email
1522553102@qq.com
Facility Name
The Third Affiliated Hospital of Shandong First Medical University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Zhang
Phone
+86-15098929972
Facility Name
Shuguang Hospital Affiliated with Shanghai University of TCM
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
210203
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Li, PhD
Phone
+86-13918191899
Email
lzwf@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yuanyuan Feng, PhD
Phone
+86-13248266010
Email
lzwf@hotmail.com
First Name & Middle Initial & Last Name & Degree
Qi Li, PhD
First Name & Middle Initial & Last Name & Degree
Yuanyuan Feng, PhD
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunke Yang
Facility Name
Affiliated Hospital of Shanxi University of Chinese Medicine
City
Xianyang
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Quan
Phone
+86-18992057958
Facility Name
Cancer Hospital of The University of Chinese Academy of Sciences
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinghua Yao
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Yangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients
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