UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013619 |
|---|---|
| Receipt number | R000015903 |
| Scientific Title | Analysis of chemotherapy induced-food preference alternation |
| Date of disclosure of the study information | 2014/04/04 |
| Last modified on | 2019/04/12 10:35:41 |
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Basic information
Public title
Analysis of chemotherapy induced-food preference alternation
Acronym
CHEF-PAL
Scientific Title
Analysis of chemotherapy induced-food preference alternation
Scientific Title:Acronym
CHEF-PAL
Region
| Japan |
Condition
Condition
Patients with solid tumor and hematologic malignancy who receive chemotherapy
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze food preference in patients who receive chemotherapy and objective evaluation of taste intensities of foods using a Taste Sensor System
Basic objectives2
Others
Basic objectives -Others
Alternation of Zn, Cu, and Na in serum and incidence rate of adverse events based on NCI-CTCAE
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of food preference alternation following chemotherapy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) patients with unresectable solid tumor and hematologic malignancy who receive chemotherapy
2) no prior chemotherapy / no radiation therapy
3) adequate use of antiemetics based on the Japanese Clinical Practice Guidelines
4) age 20 or over
5) The Eastern Cooperative Oncology Group(ECOG) Performance Status: 0~2
6) preserved organ functions
7) estimated prognosis >= 3 months
8) written informed consent was obtained
Key exclusion criteria
1) dysfunction of food intake and mastication
2) alimentary tract obstruction
3) prior local irradiation from oral cavity to esophagus
4) severe diabetes mellitus
5) uncontrolled non-malignant digestive diseases
6) other unacceptable reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Watanabe |
Organization
Oita University Faculty Of Medicine Graduate School of Medicine
Division name
Department of Medical Oncology & Hematology
Zip code
Address
1-1 Idaigaoka, Hasama-machi Yufu-shi, Oita 879-5593 Japan
TEL
097-549-4411
kwata@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Watanabe |
Organization
Oita University Faculty Of Medicine Graduate School of Medicine
Division name
Department of Medical Oncology & Hematology
Zip code
Address
1-1 Idaigaoka, Hasama-machi Yufu-shi, Oita 879-5593 Japan
TEL
097-549-4411
Homepage URL
kwata@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty Of Medicine Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Oita University Faculty Of Medicine Graduate School of Medicine, Department of Medical Oncology & Hematology
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
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
大分大学医学部附属病院（大分県）、大分県厚生連鶴見病院（大分県）、別府大学（大分県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 04 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
questionnaire survey, objective evaluation of taste intensities of foods using a Taste Sensor System
Management information
Registered date
| 2014 | Year | 04 | Month | 03 | Day |
Last modified on
| 2019 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015903
