Efficacy of Ginger and Lemon Essential Oil Inhalation on Chemotherapy-induced Nausea and Vomiting in Patients with Haematological Malignancies: a Multicenter, Double-blind, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 286
- 试验地点
- 4
- 主要终点
- Efficacy of inhaled aromatherapy on acute nausea
研究概览
简要总结
This project will optimise the management of chemotherapy-induced nausea and vomiting, with improvements in nausea and vomiting scores, quality of life and appetite expected in participants benefiting from the intervention. In all cases, the use of complementary methods is recommended and improves the management of people with cancer because they offer a person-centred approach.
详细描述
The aim is to evaluate the efficacy of inhalation of a mixture of ginger and lemon Essential Oils (EO) versus placebo in addition to conventional antiemetic treatments on the intensity of chemo-induced nausea during the acute phase D1 (H24) of its onset in patients with C1 haematological malignancies.
This multicentre study will be carried out in 5 establishments (haematology and oncology care sectors), which represents a very high potential for inclusion.
In addition, the investigator expect a very high acceptance rate for this study. In fact, in the context of CINV, this care strategy may meet a patient's expectation of symptoms (nausea, vomiting) that they find difficult to manage. Finally, it is known that patients in these care sectors are very keen on supportive care to improve their quality of life, so this is a potentially very interesting opportunity without any particular risk that is offered to participants in this study.
A nurse and a doctor with a postgraduate diploma in aromatherapy are coordinating the team, with the support of a nurse trained in evidence-based practice research methodology. Institutional procedures drawn up by the team at Limoges University Hospital describe the general procedure for using aromatherapy in a scientific and safe way, the protocols that can be used to describe the operating methods, the traceability of the manufacture of the mixtures and their administration, and the evaluation of their effectiveness. Supporting documents, an information note and a monitoring sheet have been created and are being used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 aged over 18 years,
- •Chemo-naive patients at inclusion,
- •Patients with haematological malignancies treated treated with chemotherapy,
- •Patients physically and mentally able to use the aromastick,
- •Patients who speak, read and write French,
- •Patients who have given signed consent,
- •Patients with social security cover.
排除标准
- •Asthmatic patients.
- •Patients with anosmia.
- •Patients allergic to EO, lemon or ginger.
- •Patients who have already received aromatherapy to treat chemotherapy-induced nausea and vomiting,
- •Patients practising herbal medicine or acupuncture,
- •Pregnant and breast-feeding women,
- •Patients under guardianship, tutorship or curatorship,
- •Patients taking part in interventional studies involving antiemetic drugs or nutritional products,
- •Patients who have already had cancer.
研究组 & 干预措施
Blend of ginger and lemon essential oils
The experimental group will benefit from conventional management of NVCI (antiemetic prophylaxis in accordance with ESMO international recommendations) plus an aromastick of ginger and lemon essential oils renewed with each course of chemotherapy.
Patients were included for 3 cycles of chemotherapy (C1, C2, C3).
干预措施: "Blend of ginger and lemon essential oils", "Neutral oil" (Combination Product)
Neutral oil
The control group will receive conventional management (antiemetic prophylaxis according to international recommendations, ESMO) of NVCI plus a placebo of aromastick containing a neutral, odourless oil, renewed with each course of chemotherapy.
干预措施: "Blend of ginger and lemon essential oils", "Neutral oil" (Combination Product)
结局指标
主要结局
Efficacy of inhaled aromatherapy on acute nausea
时间窗: 1 month, 2 months and 3 months
To assess difference of nausea intensity score measured by MAT Tool between groups oils (EO) of ginger and lemon versus placebo in addition to addition to conventional antiemetic treatments on intensity of chemo-induced nausea during the acute phase D1 (H24) of onset in patients with haematological malignancies C1 haematological malignancies. MAT is used to self-assess the prevention and control of chemotherapy-induced nausea and vomiting. It comprises 2 evaluation parts: the first is a Likert scale assessing the intensity of chemotherapy-induced nausea (0-10), and the second is a record of the frequency of vomiting in the acute (H24) and delayed (H96) phases of chemo-induced nausea and vomiting onset.
次要结局
- Efficacy of inhaled aromatherapy on vomiting frequency(1 day, 1 month)
- Anticipatory nausea(1 month, 2 months and 3 months)
- Compare and describe the use of antiemetics use of antiemetics(1 month, 2 months and 3 months)
- Impact of inhaled aromatherapy on quality of life(1 month, 2 months and 3 months)
- Efficacy of inhaled aromatherapy on acute nausea between 4 days and 1 month(4 days, 1 month)
- Independent determinants of the presence of nausea then vomiting(1 month, 2 months and 3 months)
- Efficacy of inhaled aromatherapy on dietary intake(1 month, 2 months and 3 months)
- Efficacy of inhaled aromatherapy on vomiting frequency between 4 days and 1 month(4 days, 1 month)
- Efficacy of inhaled aromatherapy(1 month, 2 months and 3 months)
- Compare the proportion of chemically-induced emesis(1 month, 2 months and 3 months)