Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Feasibility of Patient Enrollment and Intervention Adherence
研究概览
简要总结
This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms related to receiving chemotherapy.
详细描述
Chemotherapy drugs used to treat cancer can cause many symptoms. Some of the most common symptoms of receiving chemotherapy are nausea, vomiting, and anxiety. These symptoms can affect the quality of life of cancer patients. Medications can help ease these, but many patients continue to experience symptoms despite these treatments.
Acupuncture has been studied in clinical trials in cancer patients and has been shown to be helpful for management of pain, nerve damage from chemotherapy, and nausea.
Ear acupuncture is a type of acupuncture that involves the stimulation of points on the external ear. A few studies have suggested that ear acupuncture may help to reduce symptoms of nausea and anxiety during chemotherapy.
This study is being done to evaluate the potential benefits of using ear acupuncture to reduce symptoms like nausea and anxiety for women receiving chemotherapy for breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of histologically or cytologically proven Stage I-III breast cancer receiving intravenous chemotherapy on an every 14 days or every 21 days schedule
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Signed informed consent
排除标准
- •Receiving weekly chemotherapy
- •Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
- •Uncontrolled seizure disorder
- •Pregnancy or potential pregnancy
- •Active clinically significant uncontrolled infection
- •Prior use of acupuncture within 3 months prior to the study entry
- •Uncontrolled major psychiatric disorders, such as major depression or psychosis
- •Metastatic breast or other cancer
结局指标
主要结局
Feasibility of Patient Enrollment and Intervention Adherence
时间窗: Enrollment data over 3 months; Acupuncture attendance was recorded during Chemotherapy Cycles 2,3,4 ESAS were conducted at four time points for each cycle ESAS Assessments: Completion will were recorded up to 5 days post-infusion for Cycle 2-4
Feasibility was measured by: Enrollment of at least 20 patients (80% of the target sample size) within 3 months. Completion of at least 75% of scheduled auricular acupuncture sessions. Completion of at least 75% of ESAS assessments. Methods: Data were collected from patient enrollment logs, session attendance records, and ESAS assessment completion records.
次要结局
- Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Education Cycle (Cycle 2)(Assessed at pre-education on day 1 (T1), post-education on day 1 (T2), day 2 (T3), day 5 (T4) of cycle 2 (Education))
- Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Acupuncture Cycle (Cycle 3 and Cycle 4)(Assessed at pre-acupuncture on day 1 (T1), post-acupuncture on day 1 (T2), day 2 (T3), day 5 (T4) of cycle 3 and cycle 4 (Acupuncture Cycles). Participants were followed up to 12 weeks.)
- Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4)(STAI were collected at four time points for each of the three cycles: 1) On the day of chemotherapy infusion or day 1, pre-education/acupuncture (T1); 2) Day 1, immediate post-education/acupuncture (T2); 3) Day 2 (T3); 4) Day 5 follow-up (T4))
- Number of Participants Experienced Acupuncture-related Adverse Effects(Participants were followed up to 12 weeks.)
研究者
Weidong Lu, MB, MPH, PhD
Principal Investigator
Dana-Farber Cancer Institute