UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized controlled trial on the effects of aromatherapy for the cancer patients
Title of the study (Brief title)	The randomized controlled trial on the effects of aromatherapy for the cancer patients
Region	Japan

Condition
Condition	Hepatocellular carcinoma, Cholangiocarcinoma, Pancreatic cancer Gastric cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In aromatherapy with treatment method, we'd like to confirm the usefulness of multiple treatment. Therefore, we will conduct the prospective study comparing the group performed multiple treatments and the group performed single treatment in order to study the changes in quality of life.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Quality of life
Key secondary outcomes	Serological marker Salivary stress marker

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Multiple treatments group: 6 times/12 weeks
Interventions/Control_2	Single treatment group: once/12 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients at Juntendo University Nerima Hospital with a diagnosis of cancer clinically or histologically visit outpatient chemotherapy regulary, and their prognosis can be expected three months or more. 2.ECOG performance status of the patients with 0 or 1. 3.Patients were obtained consent by performing a sufficient explanation prior to the start of the study for the study entry.
Key exclusion criteria	1.By receiving the aromatherapy treatments, physical symptoms of the patient becomes worse. 2.Patients who can not fill out the questionnaire.
Target sample size	80

Research contact person
Name of lead principal investigator	Hironao Okubo
Organization	Juntendo University Nerima Hospital
Division name	Gastroenterology
Address	3-1-10, takanodai, nerima-ku, Tokyo, Japan
TEL	03-5923-3111
Email	drokubo@juntendo-nerima.jp

Public contact
Name of contact person	Hironao Okubo
Organization	Juntendo University Nerima Hospital
Division name	Gastroenterology
Address	3-1-10, takanodai, nerima-ku, Tokyo, Japan
TEL	03-5923-3111
Homepage URL
Email	drokubo@juntendo-nerima.jp

Sponsor
Institute	Juntendo University Nerima Hospital Gastroenterology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 11 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 10 Day
Anticipated trial start date	2013 Year 11 Month 22 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 19 Day
Last modified on	2018 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014312