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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04560114
Other study ID # CINVAROM
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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