A Randomized Controlled Trial to Evaluate the Efficacy of Acupuncture Versus Aromatherapy as Treatments to Lessen Nausea, Vomiting and Anxiety Associated With Adriamycin and Cytoxan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- improvement in anxiety
研究概览
简要总结
The overall goal of this study is to explore the effectiveness of using acupuncture versus aromatherapy, in conjunction with standard of care anti-emetics, to decrease chemotherapy induced nausea, vomiting, and anxiety in breast cancer patients undergoing Adriamycin and Cytoxan. This study also aims to determine if aromatherapy and anti-emetics is more effective than acupuncture and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan and if acupuncture and anti-emetics is more effective than aromatherapy and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 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
- •i) Inclusion
- •At least 18 years of age on the day of signing informed consent
- •Patient has a diagnosis of breast cancer
- •Patient is planned to start Adriamycin and Cytoxan chemotherapy
- •ii) Exclusion
- •Patients who are unable to adhere to the protocol or treatment schedule
- •Patients who have a concurrent illness or take medication that induces nausea independent of chemotherapy
- •Patients undergoing radiotherapy or hormone therapy during chemotherapy treatments
- •Patients who have a sensitive and/or poor sense of smell
- •Patients who are allergic to essential oils, specifically peppermint, ginger, and/or lavender
- •Patients who are already using essential oils or acupuncture for symptom management and are unwilling to stop while participating in this study
- •Patients who are afraid of or unwilling to receive acupuncture stimulation
- •Patients who are allergic to stainless steel needles
- •Thrombocytopenia (Platelets < 20,000)
- •Patients who have received aromatherapy and/or acupuncture treatment within 1 week of starting treatment on this study
排除标准
- 未提供
研究组 & 干预措施
Control Group
Acupuncture with Anti-Emetics
干预措施: Acupuncture (Other)
Aromatherapy with Anti-Emetics
干预措施: Aromatherapy (Other)
结局指标
主要结局
improvement in anxiety
时间窗: 45 days
Patients will complete an Edmonton Symptom Assessment Scale. Patients will rate their level of anxiety from 0-10 with 10 being the worst possible anxiety. Patients will also complete a symptom diary where they will track their level of anxiety and how often they are anxious.
Improvement in Nausea
时间窗: 45 days
Patients will complete an Edmonton Symptom Assessment Scale. Patients will rate their level of nausea from 0-10 with 10 being the worst possible nausea. Patients will also complete a symptom diary where they will track their level of nausea and how often they are nauseous. Patients will also complete an Anti-Emetic Diary which will track how often they are taking their anti-emetic medications to combat nausea.
improvement in vomiting
时间窗: 45 days
Patients will complete a symptom diary where they will track how often they vomit. Patients will also complete an Anti-Emetic Diary which will track how often they are taking their anti-emetic medications to combat vomiting.
次要结局
未报告次要终点