UMIN-CTR Clinical Trial

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
Last 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
Email	kwata@oita-u.ac.jp

Public contact
1st 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
Email	kwata@oita-u.ac.jp

Sponsor
Institute	Oita University Faculty Of Medicine Graduate School of Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015903