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Trial Title:
Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies
NCT ID:
NCT06150469
Condition:
Hematological Malignancies
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Vomiting
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Double-blind randomised controlled trial
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Combination Product
Intervention name:
"Blend of ginger and lemon essential oils", "Neutral oil"
Description:
Patients will be given aromasticks to inhale the blend of essential oils.
Arm group label:
Blend of ginger and lemon essential oils
Arm group label:
Neutral oil
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital, Limoges
Address:
City:
Limoges
Zip:
87042
Country:
France
Status:
Recruiting
Contact:
Last name:
Jean TONIOLO
Phone:
0555055555
Email:
Jean.TONIOLO@chu-limoges.fr
Start date:
April 17, 2024
Completion date:
December 16, 2026
Lead sponsor:
Agency:
University Hospital, Limoges
Agency class:
Other
Source:
University Hospital, Limoges
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06150469
