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NCT06150469 | RECRUITING | Hematological Malignancies


Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies
Sponsor:

University Hospital, Limoges

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.

Condition or disease

Hematological Malignancies

Intervention/treatment

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

Phase

NA

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
Estimated Enrollment : 286 participants
Masking : QUADRUPLE
Primary Purpose : PREVENTION
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
Actual Study Start Date : 2024-04-17
Estimated Primary Completion Date : 2025-12-16
Estimated Study Completion Date : 2026-12-16

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies

Location Details

NCT06150469


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

France,

CH BRIVE

Brive, France, 19100

RECRUITING

France,

chu la reunion

At Reunion, France, 97448

RECRUITING

France,

University Hospital, Limoges

Limoges, France, 87042

RECRUITING

France,

Ch Poissy

Saint-Germain-en-Laye, France, 78100

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