UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized control trial of effect of aromatherapy to prevent hypothyroidism during I-131 ablation in patients with differentiated thyroid cancer.
Title of the study (Brief title)	Effect of aromatherapy to prevent hypothyroidism during I-131 ablation.
Region	Japan

Condition
Condition	thyroid cancer
Classification by specialty	Radiology Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aims to investigate the effect of aromatherapy to prevent hypothyroidism during I-131 ablation in patients with differentiated thyroid cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	anorexia, anxiety
Key secondary outcomes	sleep, Bowel movement

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Aromatherapy using essential oil
Interventions/Control_2	control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)a patient who underwent total thyroidectomy for thyroid cancer 2)submitted written consent as a participant
Key exclusion criteria	1)a patient with cognitive impairment 2)pregnant female and feeding female 3)when medical staff determine that treatment can not be properly carried out
Target sample size	100

Research contact person
Name of lead principal investigator	Michihiro Nakayama
Organization	Asahikawa Medical University
Division name	Department of Radiology
Address	2-1-1-1 midorigaokahigashi, asahikawa, Hokkaido
TEL	0166-68-2572
Email	m-naka@asahikawa-med.ac.jp

Public contact
Name of contact person	Michihiro Nakayama
Organization	Asahikawa Medical University
Division name	Department of Radiology
Address	2-1-1-1 midorigaokahigashi, asahikawa, Hokkaido
TEL	0166-68-2572
Homepage URL
Email	m-naka@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	JSPS Grant-in-Aid for Young Scientists (B) 26861880
Organization
Division
Category of Funding Organization
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	2014 Year 05 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 01 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date
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	2014 Year 05 Month 16 Day
Last modified on	2016 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000016273