Clinical trial NCT04560114: Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)
Official title: Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nausea and Vomiting
Aromatherapy
Essential Oil
Suportive Care
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open, prospective, single-center phase 2 study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of episodes of nausea and vomiting
timeFrame: 4 days after the first cycle of chemotherapy
Secondary outcomes:
measure: Number of episodes of nausea and vomiting
timeFrame: 4 days after the third cycle
measure: Anxiety with self-questionnaire HADS
timeFrame: 21 days after the third cycle
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Francois Baclesse
Study officials:
References: