Inhaled Essential Oil Effect on Common Quality of Life Concerns During Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- Effects of essential oils on nausea and anxiety
研究概览
简要总结
This single-blind, randomized controlled trial studies how well inhaled essential oils work for common quality of life concerns in patients who are undergoing cancer treatment such as chemotherapy, targeted therapy, and/or immunotherapy given through the vein (intravenously). Aromatherapy using essential oils, such as ginger essential oil, German chamomile essential oil, and bergamot essential oil, may improve quality of life issues such as nausea, anxiety, loss of appetite, and fatigue in patients undergoing treatment for cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine if aromatherapy, specifically inhaled essential oil, is beneficial for side effects related to cancer treatments involving chemotherapy, targeted therapy, and/or immunotherapy administered intravenously.
II. To describe the effect of inhaled ginger essential oil, German chamomile essential oil, and bergamot essential oil on nausea and anxiety of patients receiving chemotherapy, targeted therapy, and/or immunotherapy administered intravenously.
III. To describe the effect of decreased levels of nausea and/or anxiety on levels of appetite and/or fatigue.
IV. To evaluate the acceptability of using a personal inhalation bottle for inhalation of essential oils.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastrointestinal cancers, neuroendocrine cancer, or melanoma or other skin cancers
- •Receiving chemotherapy, targeted therapy, and/or immunotherapy
- •Not naive to the treatment
- •Must be able to read and write English
排除标准
- •Allergies to ragweed, chrysanthemum, chamomile, ginger, bergamot, citrus fruits, tree nuts, perfumes
- •Asthma diagnosis
- •Patients receiving only octreotide injections
- •Patients receiving floxuridine (FUDR) via hepatic artery infusion (HAI) pump only
结局指标
主要结局
Effects of essential oils on nausea and anxiety
时间窗: Up to 7 days
Levels of nausea and anxiety will be measured using a numerical grading scale of 0-10. 0 will equal "good" meaning no nausea or anxiety. 10 will equal "horrible" meaning the worst nausea or anxiety. Data for each outcome will be collected 3 times a day, for a total of 21 measurements from each subject. For data analysis, we will compress the 21 measures into 3 scores. Each subject will be given a daily outcome level by averaging the 3 measures. The 7 daily outcome levels will become 3 scores by averaging data from days 1 and 2 (Period 1), days 3 and 4 (Period 2), and days 5, 6, and 7 (Period 3). Using the 3 scores, each outcome will be modeled using a repeated measures regression allowing the variability of outcome scores to vary with period. Period, group membership, the interaction between period and group membership, gender, age, and type of cancer will be model predictors. For each outcome, the contrast of interest will be that between each treatment group and the control group.
次要结局
- Determine if decreased levels of nausea and/or anxiety effect appetite and/or fatigue(Up to 7 days)
- Acceptability of using a personal inhalation bottle for inhalation of essential oils - ease of use(Up to 7 days)
- Acceptability of using a personal inhalation bottle for inhalation of essential oils - utilization post study period(Up to 7 days)
- Acceptability of using a personal inhalation bottle for inhalation of essential oils - perception of benefit of essential oil for symptoms(Up to 7 days)
研究者
Amber Williams
Principal Investigator
Ohio State University Comprehensive Cancer Center