Nausea and VomitingPhase 2CINVAROMNCT04560114
Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)
A Phase 2 study testing Essential oils in people with Nausea and Vomiting and Aromatherapy, run by Centre Francois Baclesse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea and Vomiting, Aromatherapy, Essential Oil
- What is being tested?
- Essential oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2020to 30 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Essential oils
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential oilsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Essential oils | Experimental | Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale) Receives: Drug: Essential oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Episodes of Nausea and Vomiting
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).
Measured: 4 days after the start of the first cycle of chemotherapy (5 days after inclusion in the study)
Secondary outcomes (2)
Number of Episodes of Nausea and Vomiting
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).
Measured: 4 days after the start of the third cycle of chemotherapy (2 months after inclusion).
Anxiety With Self-questionnaire HADS
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).
Measured: the last day of the third cycle of chemothrapy (3 months after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start14 Dec 2020
- Primary completion21 Sep 2021
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open, prospective, single-center phase 2 study
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560114
- Sponsor's protocol ID
- CINVAROM
- Acronym
- CINVAROM
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2020
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)
- ClinicalTrials.gov ID
- NCT04560114
- Acronym / sponsor ID
- CINVAROM / CINVAROM
- Conditions
- Nausea and Vomiting, Aromatherapy, Essential Oil, Suportive Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Posted 17 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open, prospective, single-center phase 2 study
| Arm | Type | Receives |
|---|---|---|
| Essential oils | Experimental | Drug: Essential oilsInhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential oilsThe 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. | Drug | Essential oils |
Primary outcome
Number of Episodes of Nausea and Vomiting
Time frame: 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).
2 secondary outcomes
Number of Episodes of Nausea and Vomiting
Time frame: 4 days after the start of the third cycle of chemotherapy (2 months after inclusion).
Anxiety With Self-questionnaire HADS
Time frame: the last day of the third cycle of chemothrapy (3 months after inclusion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Essential oils in people with Nausea and Vomiting and Aromatherapy, run by Centre Francois Baclesse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Episodes of Nausea and Vomiting (time frame: 4 days after the start of the first cycle of chemotherapy (5 days after inclusion in the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.