UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041414 |
|---|---|
| Receipt number | R000047122 |
| Scientific Title | Effect of aromatherapy on nausea and vomiting in cancer patients |
| Date of disclosure of the study information | 2020/08/14 |
| Last modified on | 2020/08/14 12:44:49 |
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Basic information
Public title
Effect of aromatherapy on nausea and vomiting in cancer patients
Acronym
Effect of aromatherapy on nausea and vomiting in cancer patients
Scientific Title
Effect of aromatherapy on nausea and vomiting in cancer patients
Scientific Title:Acronym
Effect of aromatherapy on nausea and vomiting in cancer patients
Region
| Japan |
Condition
Condition
cancer, digestive symptoms
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of aroma inhalation on nausea and vomiting caused by cancer or cancer treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response of nausea and vomiting using VAS scale
Key secondary outcomes
antiemetic drug use
Change of food intake
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
| Behavior,custom |
Interventions/Control_1
We evaluate the nausea and vomiting using the VAS scale after aroma inhalation once a day.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cancer inpatients with more than three hospital days.
Patients with nausea and vomiting, or loss of daily food intake less than half, over one day.
Use of emetic anti-cancer drugs.
Patient can express his physical symptoms.
Key exclusion criteria
Before and after a surgery.
Doctor in charge does not permit to entry.
Patients with intracranial lesions.
Patients with intestinal obstructions.
Patients with untreated or poor controlled hypertention.
Patients or their family do not agree participation to the study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Inoue |
Organization
Urasoe General Hospital
Division name
Nursing department
Zip code
901-2132
Address
4-16-1 Iso, Urasoe-city, Okinawa, Japan
TEL
098-878-0231
18020inoue@jin-aikai.xsrv.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Inoue |
Organization
Urasoe General Hospital
Division name
Nursing department
Zip code
901-2132
Address
4-16-1 Iso, Urasoe-city, Okinawa, Japan
TEL
098-878-0231
Homepage URL
18020inoue@jin-aikai.xsrv.jp
Sponsor or person
Institute
Urasoe General Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Urasoe General Hospital
Address
4-16-1 Iso, Urasoe-city, Okinawa, Japan
Tel
098-878-0231
ayakazuya@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 14 | 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
| 2020 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 14 | Day |
Last modified on
| 2020 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047122
