Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies (AROM-HEMATO)

University of Limoges (UL)

Status: Enrolling

Conditions: Hematological Malignancies

Treatments: Combination Product: "Blend of ginger and lemon essential oils", "Neutral oil"

Study type: Interventional

Funder types: Other

Identifiers

NCT06150469

87RI23_0013-AROM-HEMATO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 286 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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286 participants in 2 patient groups, including a placebo group

Blend of ginger and lemon essential oils

Active Comparator group

Description:

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).

Treatment:

Combination Product: "Blend of ginger and lemon essential oils", "Neutral oil"

Neutral oil

Placebo Comparator group

Description:

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.

Treatment:

Combination Product: "Blend of ginger and lemon essential oils", "Neutral oil"