Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: "Blend of ginger and lemon essential oils", "Neutral oil".
- Who it may be relevant to
- Registry conditions: Hematological Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Combination product "Blend of ginger and lemon essential oils", "Neutral oil"
Patients will be given aromasticks to inhale the blend of essential oils.
Primary outcome measures
- Efficacy of inhaled aromatherapy on acute nausea [Time frame: 1 month, 2 months and 3 months]
Secondary outcome measures (10)
- Efficacy of inhaled aromatherapy on vomiting frequency [Time frame: 1 day, 1 month]
- Efficacy of inhaled aromatherapy on acute nausea between 4 days and 1 month [Time frame: 4 days, 1 month]
- Efficacy of inhaled aromatherapy on vomiting frequency between 4 days and 1 month [Time frame: 4 days, 1 month]
- Efficacy of inhaled aromatherapy [Time frame: 1 month, 2 months and 3 months]
- Anticipatory nausea [Time frame: 1 month, 2 months and 3 months]
- Compare the proportion of chemically-induced emesis [Time frame: 1 month, 2 months and 3 months]
- Independent determinants of the presence of nausea then vomiting [Time frame: 1 month, 2 months and 3 months]
- Compare and describe the use of antiemetics use of antiemetics [Time frame: 1 month, 2 months and 3 months]
- Impact of inhaled aromatherapy on quality of life [Time frame: 1 month, 2 months and 3 months]
- Efficacy of inhaled aromatherapy on dietary intake [Time frame: 1 month, 2 months and 3 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
France · 4 centers
- CH BRIVE — Brivé
- Chu La Reunion — La Réunion
- University Hospital, Limoges — Limoges
- Ch Poissy — Saint-Germain-en-Laye
Identifiers
NCT: NCT06150469 · 87RI23_0013-AROM-HEMATO