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

Nausea and Vomiting Clinical Trial

— CINVAROM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560114
• Other study ID #: CINVAROM
• Status: Completed
• Phase: Phase 2
• Start date: December 14, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 30, 2023
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aromatherapy
• Essential Oil
• Nausea
• Nausea and Vomiting
• Suportive Care
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
France	Centre Francois Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of nausea and vomiting		4 days after the first cycle of chemotherapy
Secondary	Number of episodes of nausea and vomiting		4 days after the third cycle
Secondary	Anxiety with self-questionnaire HADS		21 days after the third cycle