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

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.

Study Overview

• Status: Completed
• Conditions: Nausea and Vomiting; Aromatherapy; Essential Oil; Suportive Care
• Intervention / Treatment: Drug: Essential oils

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Centre François Baclesse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Essential oils; Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)	Drug: Essential oils; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Episodes of Nausea and Vomiting	The proportion of patients experiencing acute and/or delayed nausea and vomiting, as diagnosed using the MASCC MAT antiemetic tool within 4 days of the first cycle of chemotherapy. Each cycle of chemotherapy lasted one month. We evaluated this criterion 4 days after the start of the first cycle of chemotherapy (5 days after inclusion in the study).	4 days after the start of the first cycle of chemotherapy (5 days after inclusion in the study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Episodes of Nausea and Vomiting	The proportion of patients experiencing acute and/or delayed nausea and vomiting, as diagnosed using the MASCC MAT antiemetic tool within 4 days of the third cycle of chemotherapy. Each cycle of chemotherapy lasted one month. We evaluated this criterion 4 days after the start of the third cycle of chemotherapy (2 months after inclusion).	4 days after the start of the third cycle of chemotherapy (2 months after inclusion).
Anxiety With Self-questionnaire HADS	The Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) consists of 7 items, yielding a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity. Each cycle of chemotherapy lasted one month. We evaluated this criterion the last day of the third cycle of chemothrapy (3 months after inclusion).	the last day of the third cycle of chemothrapy (3 months after inclusion)

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): September 21, 2021
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nausea; Vomiting; Lipids; Oils; Oils, Volatile
• Other Study ID Numbers: CINVAROM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No