UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014285 |
|---|---|
| Receipt number | R000016637 |
| Scientific Title | Examination of odor perception and emotion changes in patients undergoing chemotherapy |
| Date of disclosure of the study information | 2014/06/18 |
| Last modified on | 2016/05/05 17:26:25 |
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Basic information
Public title
Examination of odor perception and emotion changes in patients undergoing chemotherapy
Acronym
Examination of odor perception and emotion changes in patients undergoing chemotherapy
Scientific Title
Examination of odor perception and emotion changes in patients undergoing chemotherapy
Scientific Title:Acronym
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.
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
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
| 1st name | |
| Middle name | |
| Last name | Hitoshi Okamura |
Organization
Institute of Biomedical and Health Sciences, Hiroshima University
Division name
Psychosocial Rehabilitation Laboratory
Zip code
Address
2-3,Kasumi 1-chome, Minami-ku, Hiroshima, Japan
TEL
082-257-5450
hokamura@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kojiro Ishinaga |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Psychosocial Rehabilitation Laboratory
Zip code
Address
2-3,Kasumi 1-chome, Minami-ku, Hiroshima, Japan
TEL
082-555-8265
Homepage URL
koujirou@gaines.hju.ac.jp
Sponsor or person
Institute
National Hospital Higashi Hiroshima Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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
| 2014 | Year | 05 | Month | 30 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016637
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