Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies
NCT ID: NCT06150469
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
286 participants
INTERVENTIONAL
2024-04-17
2026-12-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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).
"Blend of ginger and lemon essential oils", "Neutral oil"
Patients will be given aromasticks to inhale the blend of essential oils.
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.
"Blend of ginger and lemon essential oils", "Neutral oil"
Patients will be given aromasticks to inhale the blend of essential oils.
Interventions
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"Blend of ginger and lemon essential oils", "Neutral oil"
Patients will be given aromasticks to inhale the blend of essential oils.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Limoges
OTHER
Responsible Party
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Locations
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CH BRIVE
Brivé, , France
Chu La Reunion
La Réunion, , France
University Hospital, Limoges
Limoges, , France
Ch Poissy
Saint-Germain-en-Laye, , France
Countries
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Facility Contacts
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Ludivine BESSE
Role: primary
Yacine DJAFFER
Role: primary
Jean TONIOLO
Role: primary
Christelle HILLION
Role: primary
Other Identifiers
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87RI23_0013-AROM-HEMATO
Identifier Type: -
Identifier Source: org_study_id