Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies

NCT06150469 | Recruiting

• 1 other identifier: 87RI23_0013-AROM-HEMATO
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 4

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.

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Efficacy of inhaled aromatherapy on vomiting frequency

  1 day, 1 month

• Efficacy of inhaled aromatherapy on acute nausea between 4 days and 1 month

  4 days, 1 month

• Efficacy of inhaled aromatherapy on vomiting frequency between 4 days and 1 month

  4 days, 1 month

• Efficacy of inhaled aromatherapy

  1 month, 2 months and 3 months

• Anticipatory nausea

  1 month, 2 months and 3 months

Study Arms (2)

Blend of ginger and lemon essential oils

ACTIVE COMPARATOR

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"

Neutral oil

PLACEBO COMPARATOR

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"

Interventions

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

Patients will be given aromasticks to inhale the blend of essential oils.

Blend of ginger and lemon essential oils; Neutral oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged over 18 years,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (4)

CH BRIVE

Brivé, 19100, France

RECRUITING

Chu La Reunion

La Réunion, 97448, France

RECRUITING

University Hospital, Limoges

Limoges, 87042, France

RECRUITING

Ch Poissy

Saint-Germain-en-Laye, 78100, France

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomised controlled trial

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: November 29, 2023
• Study Start: April 17, 2024
• Primary Completion: December 16, 2025
• Study Completion (Estimated): December 16, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)