UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052829 |
|---|---|
| Receipt number | R000060292 |
| Scientific Title | Trial of improvement of cachexia by ghrelin with enhanced rehabilitaion and synbiotics in patients with pancreatic cancer |
| Date of disclosure of the study information | 2023/11/17 |
| Last modified on | 2023/11/17 18:42:06 |
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Basic information
Public title
Trial of improvement of cachexia by ghrelin with enhanced rehabilitaion and synbiotics in patients with pancreatic cancer
Acronym
TIGERS-PC
Scientific Title
Trial of improvement of cachexia by ghrelin with enhanced rehabilitaion and synbiotics in patients with pancreatic cancer
Scientific Title:Acronym
TIGERS-PC
Region
| Japan |
Condition
Condition
Unresectable pancreatic cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To enhance the anti-tumor effect against pancreatic cancer and to improve the survival rate by preventing the loss of muscle mass by administering anamorelin during chemotherapy for patients with unresectable pancreatic cancer with cachexia, enhancing physical performance by exercise therapy, and continuing supportive care to improve intestinal flora by synbiotics for a long time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free survival
Rate of Conversion Surgery
Key secondary outcomes
Sarcopenia/nutritional status
Gut microbiota
Inflammatory cytokines
Comprehensive circulating cell-free tumor DNA mutation
Overall survival
Relative dose intensity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food | Behavior,custom |
Interventions/Control_1
Anamorelin is started before chemotherapy and continued until progression or conversion surgery.
Interventions/Control_2
Anamorelin and Symbiotix (Clostridium butyricum miyairi 588 and fiber) and exercise therapy are started before chemotherapy until progression or conversion surgery.
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 with unresectable pancreatic cancer with cachexia who are not taking either anamorelin or synbiotics and who understand and agree to participate in this study.
Key exclusion criteria
Patients already taking bowel regulators, fiber, or synbiotic foods at the time consent is obtained. Patients for whom exercise therapy does not appear to be feasible.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Seiko |
| Middle name | |
| Last name | Hirono |
Organization
Hyogo Medical University
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Gastroenterological Surgery
Zip code
663-8501
Address
1-1, Mukogawa town, Nishinomiya city, Hyogo prefecture, Japan
TEL
0798-45-6582
se-hirono@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Okamoto |
Organization
Hyogo Medical University
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Gastroenterological Surgery
Zip code
663-8501
Address
1-1, Mukogawa town, Nishinomiya city, Hyogo prefecture, Japan
TEL
0798-45-6582
Homepage URL
s-okamoto@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical University
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
Institutional review board Hyogo Medical University
Address
1-1, Mukogawa town, Nishinomiya city, Hyogo prefecture, Japan
Tel
0798-45-6066
rinri@hyo-med.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 | 11 | Month | 17 | 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
| 2023 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060292
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| Registered date | File name |
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