Neoplasm MetastasisRHECAPNCT02835352
Essential Oils on Anxiety of Patients Suffering From Cancer
A study testing Essential oils massages and Oil massages in people with Neoplasm Metastasis, run by Center Eugene Marquis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- Essential oils massages and Oil massages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2016to 1 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Essential Oils on Anxiety of Patients Suffering From Metastasis Cancer - Feasibility Study
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.
- Conditions
- Neoplasm Metastasis
- Being tested
- Essential oils massages, Oil massages
- Keywords
- anxiety
- Medical subject headings
- Neoplasm Metastasis, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential oils massagesOther
Oil massagesOther
| Study group | Role | What they receive |
|---|---|---|
| Essential oils then oil massages | Experimental | 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 Receives: Other: Essential oils massages; Other: Oil massages |
| Oil then essential oils massages | Experimental | 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 Receives: Other: Essential oils massages; Other: Oil massages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiolytic consumption
Anxiolytic consumption will be assessed at day 7 at the end of each phase
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start21 Jun 2016
- Primary completion1 May 2017
- Study completion1 May 2017
Why it stopped: Too slow recruitment and study data to be recorded not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès Hutin, MD, Principal investigator, Centre Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835352
- Sponsor's protocol ID
- 2014-AH-DOUL-SC
- Acronym
- RHECAP
- Status last verified
- Jan 2018
- First submitted
- 11 Jul 2016
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not authorized by French law
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Essential Oils on Anxiety of Patients Suffering From Metastasis Cancer - Feasibility Study
- ClinicalTrials.gov ID
- NCT02835352
- Acronym / sponsor ID
- RHECAP / 2014-AH-DOUL-SC
- Conditions
- Neoplasm Metastasis
- Keywords
- anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too slow recruitment and study data to be recorded not available.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential oils then oil massages | Experimental | Other: Essential oils massages, Other: Oil massagesEssential 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 then essential oils massages | Experimental | Other: Essential oils massages, Other: Oil massagesOil 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
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 oils massages | Other | Essential oils then oil massages, Oil then essential oils massages |
| Oil massages | Other | Essential oils then oil massages, Oil then essential oils massages |
Primary outcome
Anxiolytic consumption
Time frame: 7 days
Anxiolytic consumption will be assessed at day 7 at the end of each phase
Results and safety
The study was stopped early (reason given: Too slow recruitment and study data to be recorded not available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- Individual participant dataSharing planned: No. Not authorized by French law
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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.
Agnès Hutin, MD principal investigator
Centre Eugène Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential oils massages and Oil massages in people with Neoplasm Metastasis, run by Center Eugene Marquis 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 24 Jan 2018. 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.
Are results available for this study?
The study was stopped early (reason given: Too slow recruitment and study data to be recorded not available.). Results are not available in the source record.
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?
Anxiolytic consumption (time frame: 7 days). 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 24 Jan 2018.