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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nausea and Vomiting, Aromatherapy, Essential Oil, Suportive Care

Intervention / Treatment
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* Drug: Essential oils


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open, prospective, single-center phase 2 study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Essential oils<br>Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale) | Drug: Essential oils<br>* The patient will be invited to inhale the essential oils via the stick: 4 times a day before each meal and snack. if necessary when nausea appears, as many times as he deems necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of nausea and vomiting |  | 4 days after the first cycle of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of nausea and vomiting |  | 4 days after the third cycle | 
| Anxiety with self-questionnaire HADS |  | 21 days after the third cycle |