Acupuncture for Breast Cancer-related Insomnia : a Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Treatment response rate of Insomnia Severity Index (ISI)
研究概览
简要总结
Through a scientific and standardized multicenter, randomized, and controlled study method, the investigators evaluated the clinical efficacy and safety of acupuncture in the treatment of breast cancer-related insomnia, with a view to providing a reliable theoretical basis for the treatment of breast cancer-related insomnia with acupuncture.
详细描述
Insomnia associated with breast cancer is one of the most common symptoms among breast cancer patients, which seriously affects the life quality of breast cancer patients. Therefore, how to better improve their life quality and insomnia symptoms is of important clinical significance. Previous studies have shown that acupuncture may be beneficial for improving sleep disorders in cancer patients. However, the available clinical evidence is mixed, and clinical studies on acupuncture for breast cancer-associated insomnia lack well-designed, high-quality clinical evidence. The purpose of this study was to evaluate the clinical efficacy and safety of acupuncture for breast cancer-associated insomnia.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for breast cancer in the 2022 V2 edition of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology and the American Joint Committee on Cancer (AJCC) Cancer Staging Manual (8th edition) for breast cancer staging criteria meet the diagnostic criteria for breast cancer with TNM stage I to III; meet the diagnostic criteria for insomnia within the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and insomnia related to the cancer itself or to cancer-related treatment occurred after breast cancer diagnosis and lasted for at least 1 month.
- •Female patients aged 18-75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Sleep severity index scale (ISI) score ≥
- •Predicted survival of ≥ 6 months.
- •Patients had never received acupuncture treatment.
- •No mental or intellectual abnormalities, able to understand the provisions of the scales and complete the assessment.
- •Consent to participate in this study and sign a written informed consent.
排除标准
- •Combination of more serious heart, liver, kidney, and other major diseases. f applicable, indicate if participant eligibility is based on self-representation of gender identity.
- •Patients who are pregnant or breastfeeding.
- •Those with planned surgery during the trial.
- •Previous history of drug abuse or addiction.
- •Those who have taken sedative-hypnotic drugs or antipsychotic drugs 2 weeks prior to the baseline visit, or received other treatment for insomnia (e.g., cognitive behavioral therapy, etc.) 3 months prior to the baseline visit, which may affect the efficacy of the observation.
- •Insomnia due to cancer pain with an numeric rating scale (NRS) score ≥ 4, or insomnia due to other physical diseases.
- •Long-term night work or irregular rest and relaxation.
- •Ulcers, abscesses, skin infections, etc. at the site of needling.
- •Participation in other clinical medical trial studies within the last month.
结局指标
主要结局
Treatment response rate of Insomnia Severity Index (ISI)
时间窗: Week 4 (end of treatment)
The percentage of people whose total Insomnia Severity Index (ISI) score decreased by ≥8 points at the end of week 4 treatment compared to the baseline score. The ISI consists of 7 items to assess the nature and symptoms of the subject's sleep disorders. Questions addressed subjects' subjective ratings of sleep quality, including the severity of symptoms, subjects' satisfaction with their sleep patterns, the impact of the degree of insomnia on daily functioning, subjects' awareness of the impact of insomnia on themselves, and their level of frustration due to their sleep disorders. The scores were 0 to 4, with a total score range from 0 to 28. Higher scores indicate more severe insomnia. ISI levels can be classified as no clinically significant insomnia (0 to 7), mild insomnia (8 to 14), moderate insomnia (15 to 21), and severe insomnia (22 to 28).
次要结局
- Weekly usage of remedial drugs(At weeks 1, 2, 3, and 4 (end of treatment), week 8 (follow-up), and week 16(follow-up))
- Treatment remission rate of Insomnia Severity Index (ISI)(Week 4 (end of treatment), week 8 (follow-up), and week 16(follow-up))
- Sleep Efficiency (SE) with Sleep Diary(At baseline, weeks 1, 2, 3, and 4 (end of treatment))
- Generalized Anxiety Disorder Scale (GAD-7)(At baseline and week 4 (end of treatment))
- Patient Health Questionnaire-9 (PHQ-9)(At baseline and week 4 (end of treatment))
- Quality of Life Core Scale (QLQ-C30)(At baseline and week 4 (end of treatment))
- Sleep Efficiency (SE) with Actigraphy(At baseline, weeks 1 and 4 (end of treatment))
- Incidence of adverse events(During 1-4 weeks)
- Treatment response rate of Insomnia Severity Index (ISI) at follow-up visits(Week 8 (follow-up), and week 16(follow-up))
- The mean changes of Insomnia Severity Index (ISI) from baseline(Week 4 (end of treatment), week 8 (follow-up), and week 16(follow-up))
- Sleep Awakening (SA) with Actigraphy(At baseline, weeks 1 and 4 (end of treatment))
- Average Awaken Time (AA) with Actigraphy(At baseline, weeks 1 and 4 (end of treatment))
研究者
Yin Ping
Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine