Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer
研究概览
简要总结
RATIONALE: Cranial microcurrent electrical stimulation (CES) is mild electrical current received through electrodes placed on the earlobes. CES may lessen symptoms in women with breast cancer receiving chemotherapy. It is not yet known whether CES is more effective than sham therapy in reducing symptoms caused by chemotherapy in women with breast cancer.
PURPOSE: This randomized phase III trial is studying mild electrical stimulation to see how well it works compared with sham therapy in reducing symptoms caused by chemotherapy in women with stage I, stage II, or stage IIIA breast cancer receiving chemotherapy.
详细描述
OBJECTIVES:
Primary
- To compare the effects of cranial microcurrent electrical stimulation (CES) vs sham CES over time on symptoms of depression, anxiety, fatigue, pain, and sleep disturbances in women with stage I-IIIA breast cancer receiving adjuvant chemotherapy.
Secondary
- To explore the relationships among selected markers of inflammation (e.g., tumor necrosis factor alpha, interleukin-6, interleukin-1β, and C-reactive protein), symptoms, and quality of life.
- To examine whether the symptoms of depression, anxiety, fatigue, sleep disturbances, and pain form a cluster.
- To examine the effects of CES on quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer
时间窗: Up to 2 weeks afer completion of study treatment, for up to 8 months
Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire
次要结局
- Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy(Baseline)
- Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy(Midpoint Chemotherapy, up to 4 months)
- Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy(Midpoint Chemotherapy, up to 4 months)
- Relationships Among Symptom Scores - Correlations at End of Chemotherapy(Up to 2 weeks afer completion of study treatment, for up to 8 months)
- Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).(Baseline)
- Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).(Up to 2 weeks after completion of study treatment, for up to 8 months)
- Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy(Up to 2 weeks afer completion of study treatment, for up to 8 months)
- Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy(Up to 2 weeks afer completion of study treatment, for up to 8 months)
- Relationships Among Quality of Life Scores - Means at Baseline(Baseline)
- Effects of Treatment on Quality of Life - Means at End of Treatment(up to 2 weeks after completion of study treatment, for up to 8 months)
- Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).(Baseline)
- Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline(Baseline)
- Relationships Among Quality of Life Scores - Correlations at Baseline(Baseline)
- Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy(Midpoint Chemotherapy, up to 4 months)
- Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy(Midpoint Chemotherapy, up to 4 months)
- Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment(Up to 2 weeks afer completion of study treatment, for up to 8 months)
- To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.(up to 2 weeks after completion of study treatment, for up to 8 months)
- Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy(Midpoint Chemotherapy, up to 4 months)