UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057475 |
|---|---|
| Receipt number | R000065670 |
| Scientific Title | A study to determine changes in respiratory status in terminally ill cancer patients with the installation of peppermint essential oil: a feasibility study |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/04/01 10:56:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to determine changes in respiratory status in terminally ill cancer patients with the installation of peppermint essential oil: a feasibility study
Acronym
A study to determine changes in respiratory status in terminally ill cancer patients with the installation of peppermint essential oil: a feasibility study
Scientific Title
A study to determine changes in respiratory status in terminally ill cancer patients with the installation of peppermint essential oil: a feasibility study
Scientific Title:Acronym
A study to determine changes in respiratory status in terminally ill cancer patients with the installation of peppermint essential oil: a feasibility study
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to determine the changes in respiratory status and the feasibility of intervention when peppermint essential oil is placed in terminal cancer patients admitted to a palliative care unit.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Intervention Completion Rate
The percentage of all interventions that were completed.
When 90% or more of the interventions are completed, the intervention is considered feasible.
Key secondary outcomes
･ESAS-r-J (Edmonton Symptom Assessment System Revised Japanese version)
The ESAS is a self-administered symptom assessment system developed by Bruera et al. in 1991 for patients with advanced cancer. The ESAS-r-J has been revised based on problems encountered in previous versions, including the correction of items that were frequently answered incorrectly by patients. This revised version, ESAS-r-J, has been confirmed to have the same performance as the previous ESAS, while also being significantly easier to fill out.
･Vital signs (blood pressure, pulse, SpO2, dyspnea)
Tested before intervention and 20 minutes after intervention.
･Adverse events
･Scent preferences
2 hours after the intervention, on a 5-point scale (1: I don't like it at all to 5: I like it very much).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
While continuing the usual treatment, an aroma sticker impregnated with 2 drops of peppermint essential oil is applied to the patient's hospital gown within 30 cm from the patient's face.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Disease name: Cancer
(2) Stage: Advanced recurrent cancer, after completion of anticancer therapy
(3)Symptoms: dyspnea at rest
(4)SpO2 is more than 90%.
(5) The subject must have given written consent to participate in the study.
Key exclusion criteria
(1)dyspnea due to acute pneumonia
(2)Induction or base-up of opioids, steroids, or benzodiazepines within 24 hours
(3)History: asthma
(4)Allergy: peppermint
(5)Cognitive impairment
(6)Patient has olfactory impairment
(7)Persons who are considered inappropriate in the judgment of a physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mitsunori |
| Middle name | |
| Last name | Miyashita |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Palliative Nursing, Health Sciences
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7924
miya@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Satomi |
| Middle name | |
| Last name | Ito |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Palliative Nursing, Health Sciences
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7924
Homepage URL
satomi.kikuchi.q3@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東北大学病院(宮城県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 01 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065670
