The Effect and Safety of Electroacupuncture on Treating Cancer-related Depression: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale - 17 items
研究概览
简要总结
Cancer-related depression (CRD) is a common psychological condition among cancer patients during diagnosis, treatment, and recovery, and is associated with reduced quality of life, impaired immune function, and poorer clinical outcomes. As cancer incidence and mortality continue to rise in China, the psychological burden on patients is receiving increasing attention. Electroacupuncture (EA) has shown potential in treating various types of depression and related somatic symptoms, but evidence regarding its efficacy, safety, and long-term effects in CRD remains limited. This randomized controlled trial aims to evaluate the short- and long-term efficacy and safety of EA for CRD, with the goal of providing evidence to support effective and optimized treatment strategies.
详细描述
Cancer-related depression (CRD) is a prevalent and complex comorbidity among cancer patients, often arising during diagnosis, treatment, or disease progression. It is associated with a range of psychological and somatic symptoms that significantly reduce quality of life, compromise treatment adherence, and may negatively affect clinical outcomes and overall survival. As cancer incidence and mortality continue to rise in China's aging population, addressing the emotional and psychological burden of cancer has become increasingly important.
Current treatments for CRD largely rely on pharmacological interventions, particularly selective serotonin reuptake inhibitors (SSRIs). However, these medications often have delayed onset, potential side effects, and limited tolerability in patients undergoing cancer treatment. These limitations highlight the need for safe, non-pharmacological alternatives that can effectively alleviate depressive symptoms in this vulnerable population.
Acupuncture, a traditional Chinese medical therapy, has been widely used for managing depressive disorders and cancer-related symptoms. Electroacupuncture (EA), which combines needling with electrical stimulation, has demonstrated therapeutic potential in preliminary studies for depression and symptom relief in cancer patients. Despite encouraging results, the overall quality of evidence remains low, and rigorous randomized controlled trials (RCTs) focusing specifically on CRD are still lacking.
This study aims to evaluate the efficacy and safety of electroacupuncture in the treatment of CRD through a well-designed, randomized, assessor-blinded controlled trial. The trial will assess both short-term and long-term outcomes in patients with clinically diagnosed CRD, using validated measures for depression severity, quality of life, and symptom burden. Participants will be randomly assigned to either an intervention or control group, and all participants will continue to receive routine care during the study.
The results of this trial will contribute to the growing body of evidence on integrative approaches in cancer care. It aims to determine whether EA can serve as a safe and effective adjunct to conventional cancer treatment, improve patients' emotional well-being, and support a more holistic model of care. This research also aligns with national health strategies promoting integrative medicine and may inform future clinical guidelines for managing psychological distress in cancer populations.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of depression attributed to cancer itself or cancer-related treatments, meeting the diagnostic criteria for depressive disorder（DSM-V).
- •Age between 18 and 75 years, regardless of sex.
- •Hamilton Depression Rating Scale-17 (HDRS-17) total score >17 at baseline.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of ≤
- •No previous exposure to acupuncture treatment.
- •Ability to understand the study procedures and willingness to provide written informed consent.
排除标准
- •Planned to undergo surgery, chemotherapy, radiotherapy, immunotherapy, or other active cancer-related treatments during the study period.
- •History of major depressive episodes prior to cancer diagnosis.
- •Pain Rating Index (PRI) score ≥4 due to cancer-related pain.
- •Estimated life expectancy of 12 months or less.
- •Presence of severe ulcers, abscesses, or active skin infections at or near the acupuncture sites.
- •Clinically significant dysfunction of major organs, including severe cardiac, cerebral, hepatic, renal impairment; decompensated pulmonary disease; or other serious systemic illnesses.
- •Pregnant or breastfeeding women.
- •Participation in another clinical trial within the past 30 days.
- •Patients with a cardiac pacemaker or other implanted electronic medical devices.
结局指标
主要结局
Hamilton Depression Rating Scale - 17 items
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24.
The HDRS-17 is a clinician-administered scale widely used to assess the severity of depressive symptoms and evaluate treatment efficacy in clinical trials. In this study, the HDRS-17 will be administered by trained raters using structured clinical interviews. The total score ranges from 0 to 52, with higher scores indicating more severe depression. A total score \>17 is considered to reflect at least moderate depression, while a score ≤7 is typically interpreted as remission. Higher scores represent greater symptom severity.
次要结局
- Remission Rate(Week 12)
- Response Rate(Week 12)
- Patient Health Questionnaire-9(Baseline, Week 12, Week 24.)
- Pain Rating Index(Baseline, Week 12, and Week 24.)
- Quality of Life Questionnaire for Cancer Patients(Baseline, Week 12, and Week 24.)
- Use of Antidepressants(Baseline, and Week 12.)
- Treatment Emergent Symptom Scale (TESS)(Through study completion, an average of 6 months)