Trial Outcomes & Findings for Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy) (NCT NCT04560114)
NCT ID: NCT04560114
Last Updated: 2026-08-17
Results Overview
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).
COMPLETED
PHASE2
96 participants
4 days after the start of the first cycle of chemotherapy (5 days after inclusion in the study)
2026-08-17
Participant Flow
Participant milestones
| Measure |
Essential Oils
Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)
|
|---|---|
|
Overall Study
STARTED
|
96
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All patients included were described at baseline.
Baseline characteristics by cohort
| Measure |
Essential Oils
n=96 Participants
Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)
|
|---|---|
|
Age, Continuous
|
56.5 Years
n=96 Participants • All patients included were described at baseline.
|
|
Sex: Female, Male
Female
|
94 Participants
n=96 Participants • All patients included were described at baseline.
|
|
Sex: Female, Male
Male
|
2 Participants
n=96 Participants • All patients included were described at baseline.
|
PRIMARY outcome
Timeframe: 4 days after the start of the first cycle of chemotherapy (5 days after inclusion in the study)Population: Among the 96 patients included, 11 patients forget to bring back the MAT questionnaire, 2 reason unknown.
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).
Outcome measures
| Measure |
Essential Oils
n=83 Participants
Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)
|
|---|---|
|
Number of Episodes of Nausea and Vomiting
|
65 Participants
|
SECONDARY outcome
Timeframe: 4 days after the start of the third cycle of chemotherapy (2 months after inclusion).Population: Among the 96 patients included, 52 patients were not eligible for this outcome : * 5 had a organizational issue * 16 end the study prematurely * 11 forget to bring back the MAT questionnaire * 2 patients refused to take the stick of essential oils * 19 unknown reason
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).
Outcome measures
| Measure |
Essential Oils
n=44 Participants
Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)
|
|---|---|
|
Number of Episodes of Nausea and Vomiting
|
34 Participants
|
SECONDARY outcome
Timeframe: the last day of the third cycle of chemothrapy (3 months after inclusion)Population: Among the 96 patients included, 71 answer to the HADS questionnaire 21 days after third cycle of chemothrapy (reason of non answerning are patients refusal, end of study prematurely).
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).
Outcome measures
| Measure |
Essential Oils
n=71 Participants
Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)
|
|---|---|
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Anxiety With Self-questionnaire HADS
|
6 Score range bewteen 0 and 21
Interval 0.0 to 15.0
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Adverse Events
Essential Oils
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Essential Oils
n=96 participants at risk
Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)
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.
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|---|---|
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GASTROINTESTINAL DISORDERS
NAUSEA
|
78.1%
75/96 • Number of events 75 • 10 months
|
|
NERVOUS SYSTEM DISORDERS
HEADACHE
|
3.1%
3/96 • Number of events 3 • 10 months
|
|
GASTROINTESTINAL DISORDERS
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.0%
1/96 • Number of events 1 • 10 months
|
|
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
ASTHENIA
|
1.0%
1/96 • Number of events 1 • 10 months
|
|
METABOLISM AND NUTRITION DISORDERS
GOUT
|
1.0%
1/96 • Number of events 1 • 10 months
|
|
GASTROINTESTINAL DISORDERS
ABDOMINAL PAIN UPPER
|
1.0%
1/96 • Number of events 1 • 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place