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

NCT04641819 | Active Not Recruiting Phase 4

• 1 other identifier: ESPRESSO
• Study Type: interventional
• Target: 1,127
• Locations: 1 country
• Sites: 10

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.

Conditions

Carcinoma; Sleep Disorder

Keywords

Yangzheng Compound Mixture; Carcinoma; Sleep Disorder

Outcome Measures

Primary Outcomes (7)

• Best effective rate for sleep disorder treatment

  Proportion of participants with a minimum PSQI score \< 8 during the treatment period.

  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.

  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.

  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.

  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.

  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.

  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.

  Start of treatment until 30 days after the last day of the sleep disorder treatment

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Proportion of leukocyte-increasing drugs used

  Up to 18 weeks since the start of treatment

Study Arms (2)

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.

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.

Other: Conventional Treatment

Interventions

Yangzheng Compound Mixture 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.

Also known as: Z10970042（NMPA Approval Number）

Yangzheng Compound Mixture plus conventional treatment

Conventional Treatment OTHER

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

Yangzheng Compound Mixture plus conventional treatment; conventional treatment only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ShuGuang Hospital: lead
• LinkDoc Technology (Beijing) Co. Ltd.: collaborator
• Shaanxi Buchang Pharmaceutical Co., Ltd: collaborator

Study Sites (10)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Location

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Location

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410005, China

Location

The Third Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Location

Shuguang Hospital Affiliated with Shanghai University of TCM

Shanghai, Shanghai Municipality, 210203, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Location

Affiliated Hospital of Shanxi University of Chinese Medicine

Xianyang, Shanxi, China

Location

Cancer Hospital of The University of Chinese Academy of Sciences

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Carcinoma; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Qi Li, PhD

  Shuguang Hospital Affiliated with Shanghai University of TCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 24, 2020
• Study Start: April 27, 2021
• Primary Completion: September 30, 2023
• Study Completion: June 30, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)