Back to resultsEssential Oils on Anxiety of Patients Suffering From Cancer (RHECAP)
Primary Purpose
Neoplasm Metastasis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Essential oils massages
Oil massages
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis focused on measuring anxiety
Eligibility Criteria
Inclusion Criteria:
- Adult suffering from cancer at a metastatic stage
- Life expectancy > 15 days, assessed by investigator
- Hospitalized at the Chevrel unit from Centre Eugène Marquis, palliative unit care, for more than 15 days
- Regular anxiolytic treatment or imperative need to introduce anxiolytic treatment (assessed by investigator) within 48 hours following his hospitalization entry
- > 18 years
Exclusion Criteria:
- Patient already recruited in a therapeutic trial
- Patient not covered by a social security system
- Pregnant or likely pregnant patient, breastfeeding patient
- Allergy to any component of essential oils mixture and vegetable oils : bitter orange petitgrain, fine lavender, ylang-ylang, macadamia
- Minors, people deprived of their liberty or protected people,
- Impaired cognitive functions making impossible to obtain informed consent
Sites / Locations
- Centre Eugène Marquis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Essential oils then oil massages
Oil then essential oils massages
Arm Description
Essential oils massages will be done as needed during a period of 7 days, then oïl massages as needed will be done during a follow-up period of 7 days
Oil massages will be done as needed during a period of 7 days, then essential oïl massages as needed will be done during a follow-up period of 7 days
Outcomes
Primary Outcome Measures
Anxiolytic consumption
Anxiolytic consumption will be assessed at day 7 at the end of each phase
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02835352
Brief Title
Essential Oils on Anxiety of Patients Suffering From Cancer
Acronym
RHECAP
Official Title
Impact of Essential Oils on Anxiety of Patients Suffering From Metastasis Cancer - Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Too slow recruitment and study data to be recorded not available.
Study Start Date
June 21, 2016 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the impact of essential oils massage on anxiety of patients who are suffering from cancer at a metastasis stage. Half of patients will be massaged first by essential oils and then by oil only. The other half will be massaged first by oil and then by essential oils.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis
Keywords
anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Essential oils then oil massages
Arm Type
Experimental
Arm Description
Essential oils massages will be done as needed during a period of 7 days, then oïl massages as needed will be done during a follow-up period of 7 days
Arm Title
Oil then essential oils massages
Arm Type
Experimental
Arm Description
Oil massages will be done as needed during a period of 7 days, then essential oïl massages as needed will be done during a follow-up period of 7 days
Intervention Type
Other
Intervention Name(s)
Essential oils massages
Intervention Type
Other
Intervention Name(s)
Oil massages
Primary Outcome Measure Information:
Title
Anxiolytic consumption
Description
Anxiolytic consumption will be assessed at day 7 at the end of each phase
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult suffering from cancer at a metastatic stage
Life expectancy > 15 days, assessed by investigator
Hospitalized at the Chevrel unit from Centre Eugène Marquis, palliative unit care, for more than 15 days
Regular anxiolytic treatment or imperative need to introduce anxiolytic treatment (assessed by investigator) within 48 hours following his hospitalization entry
> 18 years
Exclusion Criteria:
Patient already recruited in a therapeutic trial
Patient not covered by a social security system
Pregnant or likely pregnant patient, breastfeeding patient
Allergy to any component of essential oils mixture and vegetable oils : bitter orange petitgrain, fine lavender, ylang-ylang, macadamia
Minors, people deprived of their liberty or protected people,
Impaired cognitive functions making impossible to obtain informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnès Hutin, MD
Organizational Affiliation
Centre Eugène Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not authorized by French law
Learn more about this trial
Essential Oils on Anxiety of Patients Suffering From Cancer
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