Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)

Centre Francois Baclesse

Status and phase

Completed

Phase 2

Conditions

Nausea and Vomiting

Suportive Care

Aromatherapy

Essential Oil

Treatments

Drug: Essential oils

Study type

Interventional

Funder types

Other

Identifiers

NCT04560114

CINVAROM

Details and patient eligibility

About

The investigator wish to provide a blend of two essential oils with comparable antiemetic properties; Peppermint essential oil (Mentha x Piperita) and lemon tree essential oil (Citrus Limon). Dry inhalation of these essential oils is safe, but effectiveness has not been determined. Studies on the subject present a questionable methodology. This is why we are proposing this study to measure the effectiveness of this mixture of essential oils on chemo-induced nausea and vomiting.

This study is a first step before a possible study to compare the effects of essential oils with those of a placebo.

Enrollment

96 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients will be eligible if:

Aged over 18,
Presenting a solid tumor in the 1st line of chemotherapy administered by intravenous route;
Treated with adjuvant or neoadjuvant chemotherapy;
Affiliated with a social security scheme;
Able to understand the meaning of the questions asked;
Having given their written consent to participate in the study;
Whether or not treated with surgery and radiotherapy before entering the study

Exclusion criteria

Patients who:

Do not give their consent to participate;
Do not master the French language;
Are deprived of their liberty, under guardianship or curatorship;
Suffer from cognitive deficits or associated psychiatric disorders that could compromise their ability to participate in the study (eg: schizophrenia);
Are undergoing radiotherapy;
Must receive a combination of radio-chemotherapy;
Whose chemotherapy protocol is composed of several chemotherapy administrations per week during a course of treatment;
have been previously treated with chemotherapy;
Have an occlusive syndrome;
Have primary cancer of the central nervous system or brain metastases;
Have cancer of the Upper Aero Digestive Tract;
Simultaneously participate in a therapeutic clinical trial;
Have an intolerance to a component of essential oils;
Pregnant or breastfeeding.