Nausea and Vomiting, Aromatherapy, Essential Oil, Suportive Care
Conditions
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
DRUGEssential 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.
Sponsors
Centre Francois Baclesse
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Episodes of Nausea and Vomiting | 4 days after the start of the first cycle of chemotherapy (5 days after inclusion in the study) | The proportion of patients experiencing acute and/or delayed nausea and vomiting, as diagnosed using the MASCC MAT antiemetic tool within 4 days of the first cycle of chemotherapy. Each cycle of chemotherapy lasted one month. We evaluated this criterion 4 days after the start of the first cycle of chemotherapy (5 days after inclusion in the study). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Episodes of Nausea and Vomiting | 4 days after the start of the third cycle of chemotherapy (2 months after inclusion). | The proportion of patients experiencing acute and/or delayed nausea and vomiting, as diagnosed using the MASCC MAT antiemetic tool within 4 days of the third cycle of chemotherapy. Each cycle of chemotherapy lasted one month. We evaluated this criterion 4 days after the start of the third cycle of chemotherapy (2 months after inclusion). |
| Anxiety With Self-questionnaire HADS | the last day of the third cycle of chemothrapy (3 months after inclusion) | The Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) consists of 7 items, yielding a total score ranging from 0 to 21, with higher scores indicating greater anxiety severity. Each cycle of chemotherapy lasted one month. We evaluated this criterion the last day of the third cycle of chemothrapy (3 months after inclusion). |
Countries
France
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.5 Years |
| Sex: Female, Male Female | 94 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 96 |
| other Total, other adverse events | 82 / 96 |
| serious Total, serious adverse events | 0 / 96 |
Outcome results
None listed