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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041414
Receipt No. 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

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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
Email 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
Email 18020inoue@jin-aikai.xsrv.jp

Sponsor
Institute Urasoe General Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047122

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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