Tiaoshen Anti-cancer Protocol and CBT for Insomnia and Survival in Ovarian Cancer: A Multicenter Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- PSQI Response Rate
研究概览
简要总结
Study Title: A Multicenter, Randomized Controlled Trial of Tiaoshen Anti-cancer Protocol Combined with Cognitive Behavioral Therapy for Insomnia in Improving Sleep and Survival in Ovarian Cancer Patients Purpose: This study aims to evaluate whether a combined therapy of traditional Chinese medicine (TCM) and modern psychotherapy can improve sleep and potentially extend survival for patients with ovarian cancer. Many patients experience severe, cancer-related insomnia, which lowers quality of life and may affect treatment outcomes.
Intervention & Design: This is a randomized, double-blind, placebo-controlled trial conducted across multiple hospitals. Approximately 360 eligible patients with advanced ovarian cancer and significant insomnia will be enrolled.
Participants will be randomly assigned to one of two groups for the initial 18-week phase:
Experimental Group: Receives the Tiaoshen Anti-cancer herbal formula granules plus standard Cognitive Behavioral Therapy for Insomnia (CBT-I).
Control Group: Receives inactive placebo granules plus the same standard CBT-I. Neither the participants nor their treating doctors will know which granules are assigned during this phase. The primary goal is to compare the improvement in sleep quality between the two groups. Key secondary goals include assessing the therapy's impact on patients' anxiety, depression, overall quality of life, and the length of time before the cancer progresses (progression-free survival). All patients will receive standard-of-care chemotherapy.
详细描述
This clinical trial investigates a novel integrative approach for managing cancer-related insomnia in advanced ovarian cancer. Targeting a prevalent yet under-addressed issue affecting over 60% of patients, the study evaluates the synergistic effect of combining the Tiaoshen Anti-cancer Protocol, a patented Traditional Chinese Medicine formula, with standard Cognitive Behavioral Therapy for Insomnia (CBT-I). In this multicenter, randomized, double-blind, placebo-controlled trial, approximately 360 patients with FIGO stage III-IV ovarian cancer and clinically significant insomnia will be randomized to receive either active Tiaoshen herbal granules or matched placebo for 18 weeks, with both groups concurrently receiving structured CBT-I. The co-primary endpoints are the improvement in sleep quality, measured by the Pittsburgh Sleep Quality Index response rate, and progression-free survival. Secondary objectives include assessing impacts on anxiety, depression, quality of life, and exploring predictive biomarkers. The study employs a two-stage adaptive design, where initial responders may be re-randomized to evaluate the added benefit of a mind-body exercise in a maintenance phase. This research aims to provide high-level evidence for a holistic strategy to break the "insomnia-progression" cycle, ultimately seeking to improve both quality of life and survival outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 80 years (inclusive).
- •Performance status (PS) score of 0-
- •Histologically or cytologically confirmed primary epithelial ovarian carcinoma, with postoperative FIGO stage III-IV, and scheduled to receive postoperative standard first-line platinum-based chemotherapy.
- •Having undergone ovarian cancer debulking surgery, in a stable condition at enrollment (no active infection, no severe hepatic or renal impairment, etc.), and planned for postoperative first-line platinum-based chemotherapy.
- •Meeting the diagnostic criteria for ovarian cancer-related insomnia (difficulty initiating sleep, sleep maintenance disturbance [nocturnal awakening ≥2 times], early morning awakening with inability to return to sleep, occurring ≥3 times per week and lasting ≥1 month).
- •Possess the ability to comprehend assessment scales and undergo Cognitive Behavioral Therapy for Insomnia (e.g., Mini-Mental State Examination score ≥24, or education level above primary school).
- •Voluntarily sign the informed consent form, agree to receive the study treatment, and able to independently complete a sleep diary.
排除标准
- •Previous systematic treatment with Cognitive Behavioral Therapy for Insomnia.
- •History of chronic insomnia, depression, or other psychiatric disorders prior to ovarian cancer diagnosis, AND with a Patient Health Questionnaire-9 score ≥15 and a Generalized Anxiety Disorder-7 score ≥15, AND long-term use of hypnotic or psychotropic medications.
- •Pregnant or lactating women.
- •Comorbid severe primary diseases of the cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or hematopoietic systems.
- •Language barriers that would prevent completion of assessments or therapy.
- •Comorbid autoimmune diseases, congenital or acquired immunodeficiency diseases, hematological diseases, or long-term use of corticosteroids or immunosuppressants.
- •Active hepatitis B, active tuberculosis, or other severe or uncontrolled infectious diseases.
- •History of chronic alcohol dependence.
- •Concurrent other primary malignant tumors (except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, etc.).
- •Participation in any other clinical trial within 3 months prior to enrollment.
- •Legally incompetent, or any medical or ethical reason that may hinder the continuation of the study.
研究组 & 干预措施
Tiaoshen Granules + CBT-I Group
干预措施: Tiaoshen Anti-cancer Granules (Drug)
Tiaoshen Granules + CBT-I Group
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Tiaoshen Granules + CBT-I Group
干预措施: Standard First-line Platinum-based Chemotherapy (Other)
Placebo + CBT-I Grou
干预措施: Placebo Granules (Drug)
Placebo + CBT-I Grou
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
Placebo + CBT-I Grou
干预措施: Standard First-line Platinum-based Chemotherapy (Other)
Tiaoshen Granules + Daoyin Group
干预措施: Tiaoshen Anti-cancer Granules (Drug)
Tiaoshen Granules + Daoyin Group
干预措施: Sleep-Regulating Daoyin Exercises (Behavioral)
Tiaoshen Granules + Daoyin Group
干预措施: Standard Maintenance Therapy (Other)
Tiaoshen Granules Only Group
干预措施: Tiaoshen Anti-cancer Granules (Drug)
Tiaoshen Granules Only Group
干预措施: Standard Maintenance Therapy (Other)
结局指标
主要结局
PSQI Response Rate
时间窗: Baseline, Week 18
The proportion of subjects with a reduction of ≥ 50% in the total Pittsburgh Sleep Quality Index score from baseline. PSQI is a standardized scale assessing sleep quality, with higher scores indicating poorer sleep quality.
Progression-Free Survival
时间窗: From randomization, assessed continuously up to 2 years
The time from randomization until the first observation of disease progression (according to RECIST 1.1 criteria) or death from any cause, whichever occurs first.
次要结局
- 1-Year Progression-Free Survival Rate(1 year after randomization)
- 2-Year Progression-Free Survival Rate(2 years after randomization)
- Time to First Subsequent Therapy(From the end of first-line therapy, assessed until start of second-line therapy or death (up to 2 years))
- Chemotherapy Completion Rate(During the first-line chemotherapy phase (approximately within 18 weeks))
- Change in Patient Health Questionnaire-9 Score(Baseline, Weeks 3, 6, 9, 12, 15, 18, 22, 26)
- Change in Generalized Anxiety Disorder-7 Score(Baseline, Weeks 3, 6, 9, 12, 15, 18, 22, 26)
- Change in EORTC QLQ-C30 Score(Baseline, Weeks 6, 12, 18, 22, 26)
- Change in TCM Syndrome Score(Baseline, Weeks 6, 12, 18, 22, 26)