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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hematological Malignancies
• Intervention / Treatment: Combination product: "Blend of ginger and lemon essential oils", "Neutral oil"

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.

• Study Type: Interventional
• Enrollment (Estimated): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • University Hospital, Limoges
    • Contact: Jean TONIOLO; Phone Number: 0555055555; Email: Jean.TONIOLO@chu-limoges.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Combination product: "Blend of ginger and lemon essential oils", "Neutral oil"; Patients will be given aromasticks to inhale the blend of essential oils.
Placebo Comparator: 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.	Combination product: "Blend of ginger and lemon essential oils", "Neutral oil"; Patients will be given aromasticks to inhale the blend of essential oils.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of inhaled aromatherapy on acute nausea	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.	1 month, 2 months and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of inhaled aromatherapy on vomiting frequency	To evaluate difference of vomiting fréquency measure by MAT Tool between groups. 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.	1 day, 1 month
Efficacy of inhaled aromatherapy on acute nausea between 4 days and 1 month	To assess difference of nausea intensity score measured by MAT Tool between groups. 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.	4 days, 1 month
Efficacy of inhaled aromatherapy on vomiting frequency between 4 days and 1 month	To evaluate difference of vomiting fréquency measure by MAT Tool between groups. 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.	4 days, 1 month
Efficacy of inhaled aromatherapy	To compare the efficacy of inhaled aromatherapy on the evolution of nausea intensity in the acute phase acute phase (D1) and then the delayed phase (D4) chemotherapy cycles (C1, C2 and C3). 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.	1 month, 2 months and 3 months
Anticipatory nausea	Compare the intensity of chemo-induced nausea. Compared the mean difference of anticipatory nausea intensity score measured by a Likert scale (ranging from 0-10 with zéro none and 10 as much as possible) between groups before the start of each cycle of chemotherapy (C1, C2, C3) between groups.	1 month, 2 months and 3 months
Compare the proportion of chemically-induced emesis	Compare the proportion of chemically-induced emesis before the start of each cycle of chemotherapy (C1, C2, C3) between groups.	1 month, 2 months and 3 months
Independent determinants of the presence of nausea then vomiting	To identify, in patients who received aromatherapy, the association between independent determinants of the presence of nausea then vomiting at the acute phase (D1) and at the delayed phase (D4) of the first cycle of chemotherapy (C1) (sex, age, anticipation of CINV, nausea terrain, history of nausea/vomiting, history of chemotherapy, motion sickness, tolerance of EO odour).	1 month, 2 months and 3 months
Compare and describe the use of antiemetics use of antiemetics	Compare and describe the use of antiemetics use of antiemetics and write down the use of EO inhalations EO inhalations "if needed" during the acute (D1), delayed (D4) and anticipated phase of CINV (H0) during the 3 cycles of chemotherapy (C1, C2 and C3).	1 month, 2 months and 3 months
Impact of inhaled aromatherapy on quality of life	Compare quality of life between the two groups at each each cycle of chemotherapy (C1,C2 and C3). Difference of quality of life score (EORTC QLQC30) between groups at each cycle. EORTC QLQC 30 is European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire. This self-questionnaire, validated in French, assesses quality of life specific to cancer. It is intended for all cancer patients, regardless of location. EORTC QLQC 30 contains 30 items and assesses 15 dimensions of quality of life : 5 functional scales: physical, cognitive, social, emotional or psychological and limitations in daily activities;; 1 global health/quality of life scale;; 9 symptom scales: tiredness, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation and diarrhea, financial problems related with the disease.	1 month, 2 months and 3 months
Efficacy of inhaled aromatherapy on dietary intake	To compare the effect of inhalation of ginger + lemon EO versus placebo in addition to conventional antiemetic treatments on diet during C1, C2, C3. Difference of dietary intake measured by SEFI scale between groups. SEFI (Score d'Evaluation Facile des Ingesta - Ingesta Easy Evaluation Score) / LA description : SEFI is a visual assessment, by the patient himself or with the help of a caregiver, of his food intake, using an analog scale (0 to 10), or a choice of portions consumed.	1 month, 2 months and 3 months

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Estimated): December 16, 2023
• Primary Completion (Estimated): December 16, 2025
• Study Completion (Estimated): December 16, 2026

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Signs and Symptoms, Digestive; Neoplasms; Hematologic Neoplasms; Vomiting
• Other Study ID Numbers: 87RI23_0013-AROM-HEMATO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No