UMIN-CTR Clinical Trial

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