Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Number of episodes of nausea and vomiting
研究概览
简要总结
The investigator wish to provide a blend of two essential oils with comparable antiemetic properties; Peppermint essential oil (Mentha x Piperita) and lemon tree essential oil (Citrus Limon). Dry inhalation of these essential oils is safe, but effectiveness has not been determined. Studies on the subject present a questionable methodology. This is why we are proposing this study to measure the effectiveness of this mixture of essential oils on chemo-induced nausea and vomiting.
This study is a first step before a possible study to compare the effects of essential oils with those of a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients will be eligible if:
- •Aged over 18,
- •Presenting a solid tumor in the 1st line of chemotherapy administered by intravenous route;
- •Treated with adjuvant or neoadjuvant chemotherapy;
- •Affiliated with a social security scheme;
- •Able to understand the meaning of the questions asked;
- •Having given their written consent to participate in the study;
- •Whether or not treated with surgery and radiotherapy before entering the study
排除标准
- •Patients who:
- •Do not give their consent to participate;
- •Do not master the French language;
- •Are deprived of their liberty, under guardianship or curatorship;
- •Suffer from cognitive deficits or associated psychiatric disorders that could compromise their ability to participate in the study (eg: schizophrenia);
- •Are undergoing radiotherapy;
- •Must receive a combination of radio-chemotherapy;
- •Whose chemotherapy protocol is composed of several chemotherapy administrations per week during a course of treatment;
- •have been previously treated with chemotherapy;
- •Have an occlusive syndrome;
- •Have primary cancer of the central nervous system or brain metastases;
- •Have cancer of the Upper Aero Digestive Tract;
- •Simultaneously participate in a therapeutic clinical trial;
- •Have an intolerance to a component of essential oils;
- •Pregnant or breastfeeding.
研究组 & 干预措施
Essential oils
Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)
干预措施: Essential oils (Drug)
结局指标
主要结局
Number of episodes of nausea and vomiting
时间窗: 4 days after the first cycle of chemotherapy
Number of Episodes of Nausea and Vomiting
时间窗: 4 days after the start of the first cycle of chemotherapy (5 days after inclusion in the study)
The proportion of patients experiencing acute and/or delayed nausea and vomiting, as diagnosed using the MASCC MAT antiemetic tool within 4 days of the first cycle of chemotherapy. Each cycle of chemotherapy lasted one month. We evaluated this criterion 4 days after the start of the first cycle of chemotherapy (5 days after inclusion in the study).
次要结局
- Number of episodes of nausea and vomiting(4 days after the third cycle)
- Anxiety with self-questionnaire HADS(21 days after the third cycle)
- Number of Episodes of Nausea and Vomiting(4 days after the start of the third cycle of chemotherapy (2 months after inclusion).)
- Anxiety With Self-questionnaire HADS(the last day of the third cycle of chemothrapy (3 months after inclusion))