Yangzheng Compound Mixture in the Treatment of Sleep Disorder in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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

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Carcinoma Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Yangzheng Compound Mixture

Intervention Type DRUG

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 Treatment

Intervention Type OTHER

Including treatment of sleep disorders and tumor which shall follow the clinical guidelines.

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.

Group Type OTHER

Conventional Treatment

Intervention Type OTHER

Including treatment of sleep disorders and tumor which shall follow the clinical guidelines.

Interventions

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Yangzheng Compound Mixture

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 DRUG

Conventional Treatment

Including treatment of sleep disorders and tumor which shall follow the clinical guidelines.

Intervention Type OTHER

Other Intervention Names

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Z10970042（NMPA Approval Number）

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No