Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: "Blend of ginger and lemon essential oils", "Neutral oil".
- Кому может быть актуально
- Состояния в реестре: Hematological Malignancies. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Комбинированный продукт "Blend of ginger and lemon essential oils", "Neutral oil"
Patients will be given aromasticks to inhale the blend of essential oils.
Первичные конечные точки
- Efficacy of inhaled aromatherapy on acute nausea [Срок оценки: 1 month, 2 months and 3 months]
Вторичные конечные точки (10)
- Efficacy of inhaled aromatherapy on vomiting frequency [Срок оценки: 1 day, 1 month]
- Efficacy of inhaled aromatherapy on acute nausea between 4 days and 1 month [Срок оценки: 4 days, 1 month]
- Efficacy of inhaled aromatherapy on vomiting frequency between 4 days and 1 month [Срок оценки: 4 days, 1 month]
- Efficacy of inhaled aromatherapy [Срок оценки: 1 month, 2 months and 3 months]
- Anticipatory nausea [Срок оценки: 1 month, 2 months and 3 months]
- Compare the proportion of chemically-induced emesis [Срок оценки: 1 month, 2 months and 3 months]
- Independent determinants of the presence of nausea then vomiting [Срок оценки: 1 month, 2 months and 3 months]
- Compare and describe the use of antiemetics use of antiemetics [Срок оценки: 1 month, 2 months and 3 months]
- Impact of inhaled aromatherapy on quality of life [Срок оценки: 1 month, 2 months and 3 months]
- Efficacy of inhaled aromatherapy on dietary intake [Срок оценки: 1 month, 2 months and 3 months]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
Франция · 4 центра
- CH BRIVE — Brivé
- Chu La Reunion — La Réunion
- University Hospital, Limoges — Limoges
- Ch Poissy — Saint-Germain-en-Laye
Идентификаторы
NCT: NCT06150469 · 87RI23_0013-AROM-HEMATO