Aromatherapy for Integrated Cancer Care
关键词
抽象
日期
最后验证: | 12/31/2019 |
首次提交: | 02/21/2018 |
提交的预估入学人数: | 02/21/2018 |
首次发布: | 02/27/2018 |
上次提交的更新: | 01/07/2020 |
最近更新发布: | 01/09/2020 |
实际学习开始日期: | 04/10/2018 |
预计主要完成日期: | 12/30/2020 |
预计完成日期: | 01/30/2021 |
状况或疾病
干预/治疗
Other: Ginger aromatherapy
Other: Orange aromatherpy
Other: Lavender aromatherapy
Other: Jojoba aromatherapy
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Ginger aromatherapy Ginger essential oil (GIN-106) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. | Other: Ginger aromatherapy Three sniffs of aromatherapy inhaler four times daily for seven days. |
Active Comparator: Orange aromatherpy Orange essential oil (ORG-114) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. | Other: Orange aromatherpy Three sniffs of aromatherapy inhaler four times daily for seven days. |
Active Comparator: Lavender aromatherapy Lavender essential oil (LAV-110) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. | Other: Lavender aromatherapy Three sniffs of aromatherapy inhaler four times daily for seven days. |
Placebo Comparator: Jojoba aromatherapy Jojoba oil in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. One drop of jojoba oil is on the other three aromatherapy inhalers. Jojoba oil is a "carreir oil" for essential oils which will be used as a comparator and placebo in this study. | Other: Jojoba aromatherapy Three sniffs of aromatherapy inhaler four times daily for seven days. |
资格标准
有资格学习的年龄 | 12 Years 至 12 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - a) Male and female subjects, at least 12 years of age, prescribed chemotherapy for cancer. (NOTE: Only non-pregnant females are eligible). University of Rochester will enroll young adults (i.e., 21-39 years) and adults (i.e., 40 years and older). RPCI will enroll adolescents (i.e., 12-20 years) and young adults (i.e., 21-39 years). b) Scheduled to receive three or more cycles of chemotherapy. (NOTE: Subjects may have already started chemotherapy, but must have at least three chemotherapy cycles remaining in their current prescribed course.) c) Day 1 of each chemotherapy cycle must be separated from Day 1 of the next chemotherapy cycle by at least 10 days. d) All cancer types and chemotherapy regimens are eligible. (NOTE: Monoclonal antibody therapies are allowed if administered in combination with chemotherapy). e) The chemotherapy regimen must be the same regimen for all study cycles. For example, if a subject with breast cancer was prescribed TAC for Study Cycle 1, the subject must receive TAC for Study Cycles 2 and 3. f) Any number of chemotherapy administrations per week during a chemotherapy treatment cycle is allowed. g) Subjects must agree to discontinue their current use of aromatherapy for symptom management during the course of the study. They must solely use the jojoba and aromatherapy inhalers provided by the study during the course of the study. h) Subjects must be able to read and understand English, as well as provide informed consent in order to participate in this study. Exclusion Criteria: - a) Subjects < 12 years old are not eligible for participation in this study. b) Pregnant females are ineligible for the study because pregnancy is a contraindication for chemotherapy and exposure to essentials oils. c) Subjects with more than six weeks between chemotherapy treatment cycles are not eligible. d) Concurrent radiation therapy or interferon treatment is not allowed. e) Subjects with any known allergy to ginger, lavender, orange, citrus of any kind, jojoba, or essential oils are not eligible. |
结果
主要结果指标
1. Number of participants that complete the intervention. [3 months]
2. Compliance rate [3 months]
次要成果指标
1. Mean composite severity score [3 months]
2. Maximum composite severity score [3 months]