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

NCT04560114 | Completed Phase 2

• 1 other identifier: CINVAROM
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea and Vomiting; Aromatherapy; Essential Oil; Suportive Care

Outcome Measures

Primary Outcomes (1)

• Number of episodes of nausea and vomiting

  4 days after the first cycle of chemotherapy

Secondary Outcomes (2)

• Number of episodes of nausea and vomiting

  4 days after the third cycle

• Anxiety with self-questionnaire HADS

  21 days after the third cycle

Study Arms (1)

Essential oils

EXPERIMENTAL

Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)

Drug: Essential oils

Interventions

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.

Essential oils

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (1)

Centre Francois Baclesse

Caen, 14000, France

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Oils, Volatile

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open, prospective, single-center phase 2 study

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: December 14, 2020
• Primary Completion: September 21, 2021
• Study Completion: June 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

FR (1)