Skip to content

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04560114
Acronym
CINVAROM
Enrollment
96
Registered
2020-09-23
Start date
2020-12-14
Completion date
2023-06-30
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting, Aromatherapy, Essential Oil, Suportive Care

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.

Interventions

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.

Sponsors

Centre Francois Baclesse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Open, prospective, single-center phase 2 study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of episodes of nausea and vomiting4 days after the first cycle of chemotherapy

Secondary

MeasureTime frame
Number of episodes of nausea and vomiting4 days after the third cycle
Anxiety with self-questionnaire HADS21 days after the third cycle

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026