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

NCT ID: NCT04560114

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2023-06-30

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.

Conditions

Nausea and Vomiting; Aromatherapy; Essential Oil; Suportive Care

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Essential oils

Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)

Group Type: EXPERIMENTAL

Essential oils

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Francois Baclesse

Caen, , France

Countries

France

Other Identifiers

CINVAROM

Identifier Type: -

Identifier Source: org_study_id