UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007879 |
|---|---|
| Receipt number | R000009283 |
| Scientific Title | A survey of incidence rate of taste disorder in cancer patients receiving chemotherapy |
| Date of disclosure of the study information | 2012/06/20 |
| Last modified on | 2020/05/09 20:31:34 |
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Basic information
Public title
A survey of incidence rate of taste disorder in cancer patients receiving chemotherapy
Acronym
Relationship between chemotherapy and taste disorder
Scientific Title
A survey of incidence rate of taste disorder in cancer patients receiving chemotherapy
Scientific Title:Acronym
Relationship between chemotherapy and taste disorder
Region
| Japan |
Condition
Condition
Breast / Colon / Lung cancer
Classification by specialty
| Gastroenterology | Pneumology | Gastrointestinal surgery |
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigating incidence rate and timing of taste disorder in cancer patients who underwent chemotherapy, and thereby establishing fundamental data for the future direction of the treatment of taste disorder
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence rate and timing of taste disorder in cancer patients who underwent chemotherapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Measurement of threshold of saltiness by test paper (SALSAVE)
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
1) Histologically or cytologically confirmed lung cancer, histologically proven breast and colon cancer
2) Age: 20 and over
3) Chemo-naive patient
4) ECOG performance status 2 or less
5) Life expectancy more than 3 months
6) Written informed consent
Key exclusion criteria
1) Undiagnosed disease
2) Patients incapable of taking chemotherapy
3) Severe comorbidities
4) Patient taking zinc preparation
5) Other conditions inadequate for this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yokouchi |
Organization
Fukushima Medical University
Division name
Department of Pulmonary Medicine
Zip code
960-1295
Address
1 Hikariga-oka, Fukushima
TEL
024-547-1360
hyokouch@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yokouchi |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Pulmonary Medicine
Zip code
960-1295
Address
1 Hikariga-oka, Fukushima
TEL
024-547-1360
Homepage URL
hyokouch@gmail.com
Sponsor or person
Institute
Fukushima Medical University Clinical Oncology Center
Institute
Department
Personal name
Funding Source
Organization
Department of Pulmonary Medicine, Fukushima Medical University, School of Medicine
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikariga-oka, Fukushima
Tel
024-547-1360
rs@fmu.ac.jp
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
| 2012 | Year | 06 | Month | 20 | 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
32
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
Main results already published
Date of protocol fixation
| 2012 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 02 | Day |
Last modified on
| 2020 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009283
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/05/09 | 20130821 ソルセイブ研究計画書 (最終版→期間延長→superfinal）.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/05/09 | 20130821 ソルセイブ研究計画書 (最終版→期間延長→superfinal）.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/05/09 | 20130905 味覚障害結果.ppt |
