UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050541 |
|---|---|
| Receipt number | R000057558 |
| Scientific Title | An observational study for the impact of cancer treatment on diets and food preferences of advanced cancer patients |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2025/03/31 22:11:31 |
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Basic information
Public title
An observational study for the impact of cancer treatment on diets and food preferences of advanced cancer patients
Acronym
WASHOKU trial
Scientific Title
An observational study for the impact of cancer treatment on diets and food preferences of advanced cancer patients
Scientific Title:Acronym
WASHOKU trial
Region
| Japan |
Condition
Condition
Advanced solid cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Identify a class of adverse events that reduce heat intake in cancer patients undergoing outpatient chemotherapy.
Basic objectives2
Others
Basic objectives -Others
Describe the association between adverse events, weight and diet, and preferences
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events related to the meaningful caloric intake change
Key secondary outcomes
Weight and nutrition-related items by severity and duration of each adverse event.
Describe nutrition-related items for the duration of adverse event occurrence relative to the duration of no adverse event occurrence.
Describe the weight of the period of adverse event occurrence relative to the period of no adverse event occurrence.
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
Patients who;
Be at least 20 years old
Has been informed by a physician that he/she has cancer
Be scheduled to receive new drug therapy in an outpatient chemotherapy unit at a medical facility in this country (regardless of treatment history)
Can use smartphones
Electronic written informed consent is submitted.
Key exclusion criteria
Oral intake is impossible.
Planned long-term hospitalization, such as undergoing standby surgery or undergoing major surgery during the study period
Any other information that the researcher deems inappropriate for this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Kuramochi |
Organization
NTT Medical Center Tokyo
Division name
Department of Medical Oncology
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
TEL
03-3448-6111
t3mizukami@gmail.com
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Mizukami |
Organization
NTT Medical Center Tokyo
Division name
Department of Medical Oncology
Zip code
141-8625
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
TEL
03-3448-6111
Homepage URL
https://washoku-project.com/
t3mizukami@gmail.com
Sponsor or person
Institute
NTT Medical Center Tokyo.
Institute
Department
Personal name
Takuro Mizukami
Funding Source
Organization
Self-funding
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
NTT Medical Center Tokyo
Address
5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo
Tel
03-3448-6111
t3mizukami@gmail.com
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
| 2023 | Year | 03 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study of cancer patients undergoing outpatient chemotherapy.
Patients shall be enrolled from the decision to administer drug therapy until prior to the first dose of scheduled drug therapy. If the patient meets the selection criteria, the principal investigator or sub-investigator will explain the study to the patient in writing and on video, and obtain the patient's own consent to participate. Thus, enrollment in this study is treated separately from the decision to initiate drug therapy.
Serial enrollment of eligible patients until the upper threshold for inclusion is reached or until the end of the enrollment inclusion period spanning 1.0 years (whichever is reached first). Patients will be followed from day 1 until death, withdrawal of consent, loss of follow-up/loss of records, or end of the observation period, whichever is reached first. Patient observation will end at the time of death, the date of last record for untraceable patients, the date of last evaluation, or the date of enrollment in the study (if known).
Since this is a non-interventional study, only data related to adverse events and diet will be collected at pre-specified time points. Patients will be asked to provide background information during the post-enrollment baseline period (from enrollment to day 1). Patients will be asked to enter information on adverse events once a week starting on day 1 and continuing until day 28. Patients will be asked to take images of their meals just before they are consumed from day 1 to day 28.
Management information
Registered date
| 2023 | Year | 03 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057558
