UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051309 |
|---|---|
| Receipt number | R000058526 |
| Scientific Title | Investigating the impact of a complete nutritional diet on diet-related quality of life in gastric cancer patients after gastrectomy |
| Date of disclosure of the study information | 2023/06/10 |
| Last modified on | 2023/06/12 16:28:26 |
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Basic information
Public title
Investigating the impact of a complete nutritional diet on diet-related quality of life in gastric cancer patients after gastrectomy
Acronym
Investigating the impact of a complete nutritional diet on diet-related quality of life in gastric cancer patients after gastrectomy
Scientific Title
Investigating the impact of a complete nutritional diet on diet-related quality of life in gastric cancer patients after gastrectomy
Scientific Title:Acronym
Investigating the impact of a complete nutritional diet on diet-related quality of life in gastric cancer patients after gastrectomy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine changes in diet-related quality of life before and after consumption of a complete nutritional diet in gastric cancer patients more than one year after gastrectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diet-related quality
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
| Food |
Interventions/Control_1
Eating of complete nutritional diets
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients aged 18 years and over (regardless of gender)
2 Patients who have undergone gastrectomy for the treatment of gastric cancer
3 Patients who have had outpatient consultations at least one year after gastrectomy, with a frequency of about one visit/month.
4 Patients with no evidence of recurrence of gastric cancer
5 Those who are able to consume a complete nutritional diet without difficulty.
6 Patients who have been fully informed about the enrolment in the study and who have given their free and voluntary consent based on a thorough understanding of the study.
Key exclusion criteria
1 Those who have irregular eating habits (breakfast, lunch and dinner)
2 Those who have a picky eating habits
3 Patients who are unable to properly store or consume the study food due to reasons such as not having a microwave oven
5 Patients with or at risk of developing food allergy symptoms.
6 Patients who are deemed by the principal investigator to be unsuitable to participate in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Imano |
Organization
Kindai University Faculty of Medicine
Division name
surgery
Zip code
5898511
Address
377-2 Osaka-Sayama, Ohno-Higashi, Osaka, JAPAN
TEL
072-366-0221
imano@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Motohiro |
| Middle name | |
| Last name | Imano |
Organization
Kindai University Faculty of Medicine
Division name
surgery
Zip code
5898511
Address
377-2 Osaka-Sayama, Ohno-Higashi, Osaka, JAPAN
TEL
0723660221
Homepage URL
imano@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Ethics Committee, Kindai University Faculty of Medicine
Address
377-2 Osaka-Sayama, Ohno-Higashi, Osaka, JAPAN
Tel
0723660221
imano@med.kindai.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
| 2023 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058526
