Clinical trial NCT06150469: Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematological Malignancies
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomised controlled trial
Primary purpose: PREVENTION

Brief 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.

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.

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.

Primary outcomes:
measure: Efficacy of inhaled aromatherapy on acute nausea
timeFrame: 1 month, 2 months and 3 months
Secondary outcomes:
measure: Efficacy of inhaled aromatherapy on vomiting frequency
timeFrame: 1 day, 1 month
measure: Efficacy of inhaled aromatherapy on acute nausea between 4 days and 1 month
timeFrame: 4 days, 1 month
measure: Efficacy of inhaled aromatherapy on vomiting frequency between 4 days and 1 month
timeFrame: 4 days, 1 month
measure: Efficacy of inhaled aromatherapy
timeFrame: 1 month, 2 months and 3 months
measure: Anticipatory nausea
timeFrame: 1 month, 2 months and 3 months
measure: Compare the proportion of chemically-induced emesis
timeFrame: 1 month, 2 months and 3 months
measure: Independent determinants of the presence of nausea then vomiting
timeFrame: 1 month, 2 months and 3 months
measure: Compare and describe the use of antiemetics use of antiemetics
timeFrame: 1 month, 2 months and 3 months
measure: Impact of inhaled aromatherapy on quality of life
timeFrame: 1 month, 2 months and 3 months
measure: Efficacy of inhaled aromatherapy on dietary intake
timeFrame: 1 month, 2 months and 3 months
Other outcomes:
Locations:
city: Brive
country: France
facility: CH BRIVE
city: La Reunion
country: France
facility: Chu La Reunion
city: Limoges
country: France
facility: University Hospital, Limoges
city: Saint-germain-en-laye
country: France
facility: Ch Poissy
Study officials:
References: