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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012356
Receipt No. R000014312
Scientific Title The randomized controlled trial on the effects of aromatherapy for the cancer patients
Date of disclosure of the study information 2013/11/22
Last modified on 2018/05/25

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Basic information
Public title The randomized controlled trial on the effects of aromatherapy for the cancer patients
Acronym The randomized controlled trial on the effects of aromatherapy for the cancer patients
Scientific Title The randomized controlled trial on the effects of aromatherapy for the cancer patients
Scientific Title:Acronym 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
1st name
Middle name
Last name Hironao Okubo
Organization Juntendo University Nerima Hospital
Division name Gastroenterology
Zip code
Address 3-1-10, takanodai, nerima-ku, Tokyo, Japan
TEL 03-5923-3111
Email drokubo@juntendo-nerima.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironao Okubo
Organization Juntendo University Nerima Hospital
Division name Gastroenterology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2013 Year 09 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000014312

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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