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

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Francois Baclesse

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.