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Completed

NCT Number: NCT04560114

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

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.

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Key information

Conditions

Nausea and Vomiting Aromatherapy Essential Oil Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Suportive Care Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Francois Baclesse

Caen, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Essential oils

Drug

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Number of Episodes of Nausea and Vomiting

    Time frame: 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).

  2. Anxiety With Self-questionnaire HADS

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Registry information

Acronym: CINVAROM

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Sep 23, 2020
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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