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	Time Frame
Number of episodes of nausea and vomiting	4 days after the first cycle of chemotherapy

Secondary Outcome Measures

Outcome Measure	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

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 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• 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