Aromatherapy for Chemotherapy-induced Symptoms
关键词
抽象
描述
The proposed study is an exploratory trial to evaluate the use of aromatherapy for symptom management in patients undergoing chemotherapy. The investigators will accrue 120 adult cancer subjects undergoing chemotherapy in a initial efficacy study to determine the effectiveness of three different aromatherapies (ginger, lavender, or orange) on chemotherapy-related symptoms (nausea, vomiting, pain, anxiety, sleep difficulties, fatigue, and lack of appetite) compared to placebo (i.e., jojoba). All subjects will be randomized to one of the four arms for symptom management during three different chemotherapy cycles. The investigators will examine the incidence and severity of the seven symptoms at each chemotherapy cycle. The preliminary data from this study will elucidate the relationships between certain aromatherapies and specific symptom relief, which can be further evaluated in a larger confirmatory study of subjects undergoing chemotherapy or other types of cancer treatment. This study will provide clinical evidence regarding the incorporation of aromatherapy into cancer patient care.
日期
| 最后验证: | 12/31/2018 |
| 首次提交: | 01/14/2016 |
| 提交的预估入学人数: | 01/31/2016 |
| 首次发布: | 02/01/2016 |
| 上次提交的更新: | 01/21/2019 |
| 最近更新发布: | 01/23/2019 |
| 实际学习开始日期: | 12/31/2015 |
| 预计主要完成日期: | 09/11/2018 |
| 预计完成日期: | 09/11/2018 |
状况或疾病
干预/治疗
Drug: Ginger
Drug: Lavender
Drug: Orange
Drug: Jojoba
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Ginger Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime). | Drug: Ginger The ginger oil (GIN-106) was steam distilled from fresh ginger grown in Madagascar. The ginger oil contains 64.23% sesquiterpenes, 18.5% monoterpenes, and 3.28% aldehydes. The aroma of ginger is described as spicy, sweet, and warm. |
| Experimental: Lavender Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime). | Drug: Lavender The lavender oil (LAV-110) was steam distilled from lavender grown in Kashmir Valley in India. The lavender oil contains 53.22% esters, 31.86% monoterpenols, and 4.88% oxides. The aroma of lavender is described as floral, fresh, herbaceous, and sweet. |
| Experimental: Orange Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime). | Drug: Orange The orange oil (ORG-114) was cold-pressed and steam distilled from oranges in South Africa. The orange oil contains 97.21% monoterpenes, 0.73% aldehydes, and 0.7% monoterpenols. The aroma of orange is described as citrus, fresh, fruity, and sweet. |
| Placebo Comparator: Jojoba Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime). | Drug: Jojoba The jojoba oil is certified organic and pesticide-free pure oil. Jojoba has a mild scent and can be used as a "fixative" for other essential oils. |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Non-pregnant adults between the ages of 21 to 89 years of age with diagnosis of cancer and be scheduled to receive at least three more cycles of chemotherapy. - Subjects must have had at least one chemotherapy cycle in their current prescribed course and have at least three additional chemotherapy cycles planned. - Day 1 of each chemotherapy cycle must be separated from Day 1 of the next chemotherapy cycles by at least 12 days. - All chemotherapy regimens are eligible. - Any number of chemotherapy administrations per week during a chemotherapy treatment cycle is allowed. - Subjects agree to discontinue any current aromatherapy usage and only use the study aromatherapy for symptom management during the course of the study. NOTE: Patients can continue to use scented soaps, lotions, shampoos, body sprays, perfume/cologne, candles, or air fresheners that they regularly use. - Subjects must be able to read and understand English, as well as provide informed consent in order to participate in this study. Exclusion Criteria: - Subjects < 21 years old or > 89 years old are not eligible for participation in this study at the University of Rochester. - Pregnant females are ineligible for the study because pregnancy is a contraindication for chemotherapy and exposure to essentials oils. - Subjects who are chemotherapy-naïve are ineligible. - Subjects with more than four weeks between chemotherapy treatment cycles are not eligible. - Concurrent radiation therapy or interferon treatment is not allowed. - Subjects that have used or are currently using aromatherapy inhalation for symptom management are not eligible. - Subjects with any known allergy to ginger, lavender, orange, citrus of any kind, jojoba, or essential oils. |
结果
主要结果指标
1. Mean change in severity in symptoms [up to 11 weeks]
次要成果指标
1. change in mean peak severity for nausea across all three cycles [up to 11 weeks]
2. change in mean peak severity for vomiting across all three cycles [up to 11 weeks]
3. change in mean peak severity for anxiety/distress across all three cycles [up to 11 weeks]
4. change in mean peak severity for pain across all three cycles [up to 11 weeks]
5. change in mean peak severity for fatigue across all three cycles [up to 11 weeks]
6. change in mean peak severity for sleep difficulties across all three cycles [up to 11 weeks]
7. change in mean peak severity for lack of appetite across all three cycles [up to 11 weeks]
8. the number of participants who found the aromatherapy acceptable [up to 11 weeks]
