UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050927 |
|---|---|
| Receipt number | R000058034 |
| Scientific Title | The usefulness of nutrition and prehabilitation therapy during neoadjuvant chemotherapy for resectable pancreatic cancer:A prospective observational study |
| Date of disclosure of the study information | 2023/04/25 |
| Last modified on | 2025/03/11 18:38:09 |
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Basic information
Public title
The usefulness of nutrition and prehabilitation therapy during neoadjuvant chemotherapy for resectable pancreatic cancer:A prospective observational study
Acronym
The usefulness of nutrition and prehabilitation therapy during neoadjuvant chemotherapy for resectable pancreatic cancer
Scientific Title
The usefulness of nutrition and prehabilitation therapy during neoadjuvant chemotherapy for resectable pancreatic cancer:A prospective observational study
Scientific Title:Acronym
The usefulness of nutrition and prehabilitation therapy during neoadjuvant chemotherapy for resectable pancreatic cancer
Region
| Japan |
Condition
Condition
resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of nutrition and prehabilitation therapy during neoadjuvant chemotherapy for resectable pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
comparing Nutritional index(Body weight,BMI:body mass index,albumin,PNI:prognostic nutritional index,GPS:glasgow prognostic score,modifiedGPS,NLR:Neutrophile lymphocyte ratio,PLR:Platelet lymphocyte ratio) to historical controls
Key secondary outcomes
Postoperative complications and length of hospital stay
Adverse events during neoadjuvant chemotherapy
Skeletal muscle mass index,grip strength,6 minute walk test
Change in quality of life from the start of chemotherapy to before surgery
Completion rate of adjuvant chemotherapy(6 months)
Overall survival
Recurrence free survival
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with newly diagnosed resectable pancreatic cancer and neoadjuvant chemotherapy
2)Patients with pathologically confirmed diagnosis of pancreatic cancer
Key exclusion criteria
1) Patients with postoperative recurrence of pancreatic cancer
2) Patients who are unable to undergo surgery after neoadjuvant chemotherapy
3) Patients who are judged to be ineligible for this study by the investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Oki |
| Middle name | |
| Last name | Kentaro |
Organization
Kurashiki central hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
7108602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
0864220210
p023eb@gmail.com
Public contact
Name of contact person
| 1st name | Oki |
| Middle name | |
| Last name | Kentaro |
Organization
Kurashiki Central Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
7108602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
0864220210
Homepage URL
p023eb@gmail.com
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kurashiki Central Hospital
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
Tel
0864220210
kenkyu@kchnet.or.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 | 04 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058034
