UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of odor perception and emotion changes in patients undergoing chemotherapy
Title of the study (Brief title)	Examination of odor perception and emotion changes in patients undergoing chemotherapy
Region	Japan

Condition
Condition	digestive cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We try to estimate the odor perception changes of the patients with the anticancer drug administration. At the same time, We try to grasp the emotion changes in patients for smells of Odor Stick Identification Test for Japanese(OSIT-J).
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Odor Stick Identification Test for Japanese(OSIT-J) The intervention times of the examination of odor perception are at the three times that are ago, during, after the anticancer drug administration in one anticancer drug treatment course.
Key secondary outcomes	1.Visual Analogue Scale(VAS) estimating emotion affected by odor perception 2. physiological indicators temperature, percutaneous oxygen saturation of the arterial blood, a pulse rate, blood pressure 3. Biochemical examination of blood Alb, Hgb, Hct, RBC, WBC, Lympho, Plt, MCV, Cr, BUN, FBS, AST, ALT, Na 4. The questionnaire writing by oneself about the smell The intervention times are at the three times that are ago, during, after the anticancer drug administration in one anticancer drug treatment course. However,we do not perform the biochemical examination of blood during treatment with anticancer drug.

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Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	The subjects perform in the same patient, the intervention times of the examination of odor perception and emotion are at the three times that are ago, during, after the anticancer drug administration in one anticancer drug treatment course. The investigation contents are odor Stick Identification Test for Japanese (OSIT-J), Visual Analogue Scale(VAS) estimating emotion affected by odor perception, physiological indicators, biochemical examination of blood, and the questionnaire writing by oneself about the smell.However,we do not perform the biochemical examination of blood during treatment with anticancer drug. Identification Test for Japanese (OSIT-J) uses 12 kinds of odorant (China ink, wood, perfume, menthol, orange, curry, home gas, rose, hinoki, steamed socks, condensed milk, the fried garlic).
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

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The inpatients, communication does not have a hindrance, are adults who are treated with the digestive cancer chemotherapy, and are available for oral intake , and 20 years-old or older.
Key exclusion criteria	The persons except the key inclusion criteria
Target sample size	10

Research contact person
Name of lead principal investigator	Hitoshi Okamura
Organization	Institute of Biomedical and Health Sciences, Hiroshima University
Division name	Psychosocial Rehabilitation Laboratory
Address	2-3,Kasumi 1-chome, Minami-ku, Hiroshima, Japan
TEL	082-257-5450
Email	hokamura@hiroshima-u.ac.jp

Public contact
Name of contact person	Kojiro Ishinaga
Organization	Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name	Psychosocial Rehabilitation Laboratory
Address	2-3,Kasumi 1-chome, Minami-ku, Hiroshima, Japan
TEL	082-555-8265
Homepage URL
Email	koujirou@gaines.hju.ac.jp

Sponsor
Institute	National Hospital Higashi Hiroshima Medical Center
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	Hiroshima Jogakuin University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Hospital Higashi Hiroshima Medical Center
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	国立病院機構東広島医療センター（広島県）

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 30 Day
Anticipated trial start date	2014 Year 06 Month 18 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 07 Month 31 Day
Date trial data considered complete	2015 Year 09 Month 30 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	We investigated a change of odor identification ability using Odor Stick Identification Test for Japanese in ten patients who have received the sequential chemotherapy of FOLFIRI or modified FOLFOX6 therapy. As a result, we was speculated that the odor identification ability did not decrease, because the significant difference was not found at three times of the examination of odor perception that are ago, during, after the anticancer drug administration in one anticancer drug treatment course. But, patients felt heightened sensitivity to odors, we was thought to have possibilities to appear that heightened sensitivity to odors were stress reaction related to protect oneself as evidenced by pulses increased after anticancer drug administration, when patients felt emotional psychologic stresses by anticancer drug administration.
Other related information

Management information
Registered date	2014 Year 06 Month 17 Day
Last modified on	2016 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016637