Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies

NCT06150469 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Limoges

Phase

Not applicable

Started

2024-04-17

Last updated

2024-12-12

Condition(s) studied

Hematological Malignancies

Investigational drug(s) / intervention(s)

"Blend of ginger and lemon essential oils", "Neutral oil"

"Blend of ginger and lemon essential oils", "Neutral oil": Patients will be given aromasticks to inhale the blend of essential oils.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Efficacy of inhaled aromatherapy on acute nausea — 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.

Trial sites (4)

Facility	City	Region	Status
CH BRIVE	Brivé	France	Recruiting
Chu La Reunion	La Réunion	France	Recruiting
University Hospital, Limoges	Limoges	France	Recruiting
Ch Poissy	Saint-Germain-en-Laye	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06150469 on ClinicalTrials.gov ↗ ← All trials in France