The Role of Chinese Acupuncture for Chemotherapy Induced Cognitive Impairment in Elderly Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- The incidences of adverse events
研究概览
简要总结
Elderly cancer patients would suffer cognitive impairment due to chemotherapy, and a series of neurocognitive symptoms, known as "chemobrain". Chinese acupuncture plus herbal decoctions is an emerging therapeutic option for chemotherapy induced cognitive impairment in elderly cancer patients, despite limited supporting evidence. By evaluating this novel Chinese medicine mode in elderly cancer patients at our institution, the investigators aim to contribute to the existing knowledge in this area while establishing a basis for further research.
The investigators will perform a study of all cases of "chemobrain" related elderly cancer patients treated with Chinese acupuncture from 2023 to 2025. The investigators would enroll 168 elderly cancer patients with clinically confirmed chemobrain; those for Chinese acupuncture will be treated with electroacupuncture (2 sessions per week over 8 weeks) ; the others will be received conventional drug therapy, or palliative-intent therapy. The Montreal Cognitive Assessment (MoCA) will be served as the primary outcome. Digit span test will be the secondary outcome for attentional function and working memory. The quality of life and multiple functional assessments will also be evaluated.
详细描述
Elderly cancer patients would suffer cognitive impairment due to chemotherapy, and a series of neurocognitive symptoms, known as "chemobrain". Chinese acupuncture plus herbal decoctions is an emerging therapeutic option for chemotherapy-induced cognitive impairment in elderly cancer patients, despite limited supporting evidence. By evaluating this novel Chinese medicine mode in elderly cancer patients at our institution, the investigators would like to contribute to the existing knowledge in this area while establishing a basis for further research.
This randomized controlled trial would be conducted from Jan 2023 to December 2025 in clinics of Nanjing 1st Hospital, Nanjing, China. Potentially eligible patients will be recruited through clinical oncologists' referral from local hospital and advertisement. The study protocol should be approved by Institutional Review Board(IRB) of the Nanjing 1st Hospital. The investigators will enroll 168 elderly cancer patients with clinically confirmed chemobrain.
Acupuncture intervention will be conducted for 2 sessions per week over 8 consecutive weeks. The determination of 8 weeks of the treatment duration will be based on the fact that the robust effects of acupuncture in cancer patients will be generally observed within 8 weeks of treatment.
The primary outcome will be measured using the Montreal Cognitive Assessment(MoCA) which has been extensively used in the study of cognitive disorders. The forward and reverse digit span test would serve the secondary outcomes to detect attentional function and working memory. In addition, EORTCQLQ-C30 will be used to examine the quality of life of elderly cancer patients. Functional changes and side effects associated with therapies will be measured using the Functional Assessment of Cancer Therapy (FACT), Functional Assessment of Chronic Illness Therapy (FACIT), Functional Assessment of Anorexia/Cachexia Therapy (FAACT), Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane), and Functional Assessment of Cancer Therapy-Biologic Response Modifier (FACT-BRM). These instruments have been widely used in elderly cancer patients. Most items of these functional assessments are 5-point Likert scale questions. Functional items which would be rated as "3" (quite a bit) or higher and incidences would be significantly different between the two groups in any assessment point will be extracted for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elderly cancer patients >60 years old;
- •Patients clinically confirmed with malignant tumor ;
- •Chemotherapy related cognitive impairment anticipated.
排除标准
- •Chemotherapy received in the past two years;
- •Implanted pacemaker in the body and epilepsy or other unstable diseases.
- •Participated in drug research within the past six years;
- •Alcohol or drug abuse in the past years;
- •Fear of needles;
- •History of stroke or head trauma;
- •Have a history of mood disorders or mental illness.
结局指标
主要结局
The incidences of adverse events
时间窗: up to Week 8
The incidences of adverse events
Changes in score on MoCA
时间窗: Baseline, Week 2, Week 4, Week 6, Week 8
The primary outcome will be measured using the Montreal Cognitive Assessment(MoCA)
次要结局
未报告次要终点
研究者
Gong yongling,MD
PI
Nanjing First Hospital, Nanjing Medical University