The Effects of Inhaled Aromatherapy on Chemotherapy Induced Nausea and Vomiting (CINV) in Men and Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Delayed Nausea Score
研究概览
简要总结
This study is a three group, randomized, double blind, placebo-controlled trial with two repeated measurements. The same measurements will be collected for each participant during two consecutive chemotherapy treatment cycles.Subjects will be provided with written instructions as an educational handout as well as essential oil safety information. Subjects will be able to demonstrate an ability and accurate understanding of the proper use of the diffusers, using a demonstration diffuser, at the time of consent.
At the time the subject will provide written informed consent, they will be randomly assigned to one of the three groups with a pocket diffuser containing either ginger essential oil, peppermint essential oil, or vanilla extract )placebo- control). This is based on a pre-determined list of random assignments.
Each subject will be instructed to inhale from the pocket diffuser beginning on the day of their chemotherapy (Day 1) and continue using the inhaler for the next three consecutive days (Day 1-Day 4). The subjects will remove the cover of the pocket diffuser, place the pocket diffuser approximately an inch away from their nose and inhale three times with deep breathing (i.e., three sniffs). Subjects will take 3 sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening).
In addition to the Pre-treatment Assessment, occurring before each of the 2 cycles of chemotherapy, the subjects will be contacted to complete assessments at approximately 24 and 72 hours post-chemotherapy. A member of the study team will call the participant again at their preferred time of day to ask the survey questions.
The same procedures will be repeated during the participant's second cycle of chemotherapy, which is likely two or three weeks after the first one.
详细描述
This study is a three group, randomized, double blind, placebo-controlled trial with two repeated measurements. The same measurements will be collected for each participant during two consecutive chemotherapy treatment cycles.
After subjects are identified to meet criteria and have reported some degree of nausea following chemotherapy, one of the Clinical Nurse Coordinators or Infusion Room Nurses on the research team will provide information regarding the study to the potential subject. If the potential subject is interested in participating in the study and physically demonstrates the ability to correctly use the pocket diffuser the consent will be gone over in detail with the potential subject and signed. Educational handouts outlining the instructions for use of the pocket diffuser as well as safety and contact information will be provided and explained to the subject at this time.
At the time the subject will provide written informed consent, they will be randomly assigned to one of the three groups (ginger essential oil, peppermint essential oil, or vanilla extract placebo- control) based on a pre-determined list of random assignments.
The diffusers will have been prepped with essential oils of either peppermint or ginger, which will each contain 14 drops of the designated essential oil. The nonessential oil diffusers (placebo) pure vanilla extract will also be prepared to each contain 14 drops each.
Prior to the start of the participant's chemotherapy infusion, all subjects will complete a pre-treatment survey to evaluate their baseline/anticipatory nausea. The pre-treatment survey will also include questions about the recent chemotherapy treatment experience related to appetite and the use of medication to prevent or lesson nausea.
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)
盲法说明
Subjects and all members of the research team will not know which group, either peppermint essential oil, ginger essential oil, or placebo (vanilla extract group), the potential subject would be randomly assigned to as the research team members involved in consenting will open a prefilled envelope to determine the group which will be labeled with the correlating diffuser (A, B, or C).
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women included
- •Ages between 21 years old and 89 years old
- •Diagnosis of breast cancer - all histologies and stages
- •Subjects must have reported some degree of nausea following chemotherapy
- •Subjects must have at least two remaining cycles of chemotherapy to complete
- •Subjects must be fluent in English or Spanish
- •Subjects must be willing to complete questionnaire through follow-up phone calls
- •Subjects must be able to use the pocket diffuser
排除标准
- •Inability to sign the consent
- •Pregnancy
- •Cognitive impairment
- •Current use of aromatherapy for symptom management or prevention
- •Allergies to peppermint, ginger, or vanilla
- •Concurrent radiation therapy
结局指标
主要结局
Delayed Nausea Score
时间窗: 72 hours post-chemotherapy
N\&V that occurs more than 24 hours after chemotherapy administration , as measured by the Memorial Symptom Assessment Scale's nausea and vomiting dimension, with values for symptoms, if experienced, on a 4-point scale; its frequency, if appropriate, on a 4-point scale; and its associated distress on a 5-point categorical scale. The higher the score determines a worse outcome in all areas.
Acute Nausea Score
时间窗: 24 hours post-chemotherapy
N\&V experienced during the first 24 hours after chemotherapy administration as measured by the Memorial Symptom Assessment Scale's nausea and vomiting dimension with values for symptoms, if experienced, on a 4-point scale; its frequency, if appropriate, on a 4-point scale; and its associated distress on a 5-point categorical scale. The higher the score determines a worse outcome in all areas.
次要结局
- Appetite During the 72 Hours Post-chemotherapy(72 hours post-chemotherapy)
- Appetite For the 24 Hours Post-chemotherapy(24 hours post-chemotherapy)
- Use of additional anti-emetic medications (in addition to the standard regimen's listed anti-emetics)(72 hours post-chemotherapy)