CarcinomaPhase 4NCT04641819
Yangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients
A Phase 4 study testing Yangzheng Compound Mixture and Conventional Treatment in people with Carcinoma and Sleep Disorder, run by ShuGuang Hospital at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Sleep Disorder
- What is being tested?
- Yangzheng Compound Mixture and Conventional Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,127 participants
- Where
- 10 sitesChina
- Study dates
- 27 Apr 2021to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
The Second Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410005
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang
The Third Affiliated Hospital of Shandong First Medical University
Jinan, Shandong
Shuguang Hospital Affiliated with Shanghai University of TCM
Shanghai, Shanghai Municipality, 210203
Zhongshan Hospital
Shanghai, Shanghai Municipality
Affiliated Hospital of Shanxi University of Chinese Medicine
Xianyang, Shanxi
Henan Cancer Hospital
Zhengzhou, Henan
About this study
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
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.
Read the 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.
- Conditions
- Carcinoma, Sleep Disorder
- Being tested
- Yangzheng Compound Mixture, Conventional Treatment
- Keywords
- Yangzheng Compound Mixture, Carcinoma, Sleep Disorder
- Medical subject headings
- Carcinoma, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yangzheng Compound MixtureDrug
Also called Z10970042（NMPA Approval Number）
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.
Conventional TreatmentOther
Including treatment of sleep disorders and tumor which shall follow the clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Yangzheng Compound Mixture plus conventional treatment | Experimental | 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. Receives: Drug: Yangzheng Compound Mixture; Other: Conventional Treatment |
| conventional treatment only | Other | 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. Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best effective rate for sleep disorder treatment
Proportion of participants with a minimum PSQI score < 8 during the treatment period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 6.
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.
Measured: 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.
Measured: 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.
Measured: Start of treatment until 30 days after the last day of the sleep disorder treatment
Secondary outcomes (5)
Use frequency of hypnotic agents
Response to question 6 of the PSQI scale.
Measured: Up to 18 weeks since the start of treatment
Appetite
Appetite was evaluated by using the Cancer Appetite and Symptom Questionnaire(CASQ).
Measured: Up to 18 weeks since the start of treatment
Fatigue
Fatigue was evaluated by using the Brief Fatigue Inventory(BFI).
Measured: 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).
Measured: 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.
Measured: Up to 18 weeks since the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start27 Apr 2021
- Primary completion30 Sep 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,127 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Shaanxi Buchang Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Qi Li, ShuGuang Hospital
- Investigators
- Qi Li, PhD, Principal investigator, Shuguang Hospital Affiliated with Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641819
- Sponsor's protocol ID
- ESPRESSO
- Status last verified
- May 2024
- First submitted
- 6 Nov 2020
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04641819
- Acronym / sponsor ID
- ESPRESSO
- Conditions
- Carcinoma, Sleep Disorder
- Keywords
- Yangzheng Compound Mixture, Carcinoma, Sleep Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,127 participants (actual)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd., Shaanxi Buchang Pharmaceutical Co., Ltd
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yangzheng Compound Mixture plus conventional treatment | Experimental | Drug: Yangzheng Compound Mixture, Other: Conventional TreatmentYangzheng 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. |
| conventional treatment only | Other | Other: Conventional TreatmentAntitumor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yangzheng Compound MixtureAlso: Z10970042（NMPA Approval Number）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. | Drug | Yangzheng Compound Mixture plus conventional treatment |
| Conventional TreatmentIncluding treatment of sleep disorders and tumor which shall follow the clinical guidelines. | Other | Yangzheng Compound Mixture plus conventional treatment, conventional treatment only |
Primary outcome
Best effective rate for sleep disorder treatment
Time frame: Measurement was taken at week 6.
Proportion of participants with a minimum PSQI score < 8 during the treatment period.
Effective rate for sleep disorder treatment
Time frame: Measurement was taken at week 6.
Proportion of participants with PSQI score < 8 after the end of the different treatment courses.
Improvement rate for sleep disorder treatment
Time frame: Measurement was taken at week 6.
Proportion of participates whose PSQI score decreased during treatment compared with the baseline.
Change of PSQI score compared with baseline
Time frame: Baseline and week 6.
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.
Time frame: 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.
Incidence and severity of AE or SAE
Time frame: 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.
Incidence and severity of ADR or SADR
Time frame: 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.
5 secondary outcomes
Use frequency of hypnotic agents
Time frame: Up to 18 weeks since the start of treatment
Appetite
Time frame: Up to 18 weeks since the start of treatment
Fatigue
Time frame: Up to 18 weeks since the start of treatment
Quality of life (QOL)
Time frame: Up to 18 weeks since the start of treatment
Traditional Chinese Medical symptoms scale
Time frame: Up to 18 weeks since the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Li, PhD principal investigator
Shuguang Hospital Affiliated with Shanghai University of TCM
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yangzheng Compound Mixture and Conventional Treatment in people with Carcinoma and Sleep Disorder, run by ShuGuang Hospital at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best effective rate for sleep disorder treatment (time frame: Measurement was taken at week 6.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.