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

Primary Purpose

Nausea and Vomiting, Aromatherapy, Essential Oil

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Essential oils
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Francois Baclesse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Essential oils

Arm Description

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

Outcomes

Primary Outcome Measures

Number of episodes of nausea and vomiting

Secondary Outcome Measures

Number of episodes of nausea and vomiting
Anxiety with self-questionnaire HADS

Full Information

First Posted
September 17, 2020
Last Updated
July 31, 2023
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT04560114
Brief Title
Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)
Acronym
CINVAROM
Official Title
Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
September 21, 2021 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Aromatherapy, Essential Oil, Suportive Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open, prospective, single-center phase 2 study
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Essential oils
Arm Type
Experimental
Arm Description
Inhalation will be carried out via an inhaler stick containing essential oils (Mentha x Piperita; Citrus Limon; Zingiber Officinale)
Intervention Type
Drug
Intervention Name(s)
Essential oils
Intervention Description
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 Outcome Measure Information:
Title
Number of episodes of nausea and vomiting
Time Frame
4 days after the first cycle of chemotherapy
Secondary Outcome Measure Information:
Title
Number of episodes of nausea and vomiting
Time Frame
4 days after the third cycle
Title
Anxiety with self-questionnaire HADS
Time Frame
21 days after the third cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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