UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040392 |
|---|---|
| Receipt number | R000046034 |
| Scientific Title | Effectiveness of pancreatic enzyme replacement therapy for patients with unresectable pancreatic cancer; a prospective cohort study |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2025/08/22 10:48:49 |
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Basic information
Public title
Effectiveness of pancreatic enzyme replacement therapy for patients with unresectable pancreatic cancer; a prospective cohort study
Acronym
Effectiveness of pancreatic enzyme replacement therapy for patients with unresectable pancreatic cancer; a prospective cohort study(AOE study2)
Scientific Title
Effectiveness of pancreatic enzyme replacement therapy for patients with unresectable pancreatic cancer; a prospective cohort study
Scientific Title:Acronym
Effectiveness of pancreatic enzyme replacement therapy for patients with unresectable pancreatic cancer; a prospective cohort study(AOE study2)
Region
| Japan |
Condition
Condition
unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of pancreatic enzyme replacement therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Serum albumin at 3 months compare with historical control
Key secondary outcomes
compare with historical control below
1.serum total protein at 3 months
2.HbA1c at 3 months
3.how long days patients could receive chemotherapy
4.over all survival
5.body mass index at 3 months
6.how many pancreatic enzyme drugs patients could have at 3 months
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.previously untreated and histopathologically confirmed unresectable pancreatic cancer patients
2.provided written informed consent
Key exclusion criteria
1.severe complication
2.disability of oral intake
3.Inflammatory bowel disease
4.ECOG scale of performance status 3-4
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Harada |
Organization
Japanese Red Cross Okayama Hospital
Division name
Department of Gastroenterology
Zip code
700-8607
Address
2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
TEL
086-222-8811
oka-rcgh@okayama-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Harada |
Organization
Japanese Red Cross Okayama Hospital
Division name
Department of Gastroenterology
Zip code
700-8607
Address
2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
TEL
086-222-8811
Homepage URL
oka-rcgh@okayama-med.jrc.or.jp
Sponsor or person
Institute
Department of Gastroenterology, Japanese Red Cross Okayama 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
Japanese Red Cross Okayama Hospital
Address
2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
Tel
0862228811
oka-rcgh@okayama-med.jrc.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
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view.cgi?recptno=R000046034
Publication of results
Published
Result
URL related to results and publications
https://mol.medicalonline.jp/library/journal/download?GoodsID=ck8syokb/2023/v120s1/092&name=5334-533
Number of participants that the trial has enrolled
39
Results
In patients with unresectable pancreatic cancer undergoing chemotherapy, the addition of pancreatic enzyme replacement therapy (PERT) significantly improved nutritional status. After 3 months, the PERT group showed significantly better outcomes in serum albumin, total protein, and PNI compared to the non-PERT group.These findings suggest the potential benefit of PERT in maintaining nutritional status during pancreatic cancer treatment.
Results date posted
| 2025 | Year | 08 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 06 | Month | 04 | Day |
Baseline Characteristics
Participants were patients with unresectable pancreatic cancer receiving initial chemotherapy at Okayama Red Cross Hospital. The PERT group (n=39) had more females; the non-PERT group (n=37) had more males. Age, BMI, PS, tumor site/stage, and markers were similar. FOLFIRINOX was more common in the PERT group, while Gem+nab-PTX dominated in the non-PERT group. Diabetes was more frequent in the non-PERT group, but nutritional status (PNI) was comparable.
Participant flow
A total of 39 patients with unresectable pancreatic cancer were enrolled at Okayama Red Cross Hospital. Three patients dropped out due to loss to follow-up or other reasons, leaving 36 patients for final analysis. Participants were divided into PERT and non-PERT groups for evaluation of primary outcomes.
Adverse events
In this study, no serious adverse events related to pancreatic enzyme replacement therapy (PERT) were observed. Chemotherapy-related adverse events, such as myelosuppression and gastrointestinal symptoms, occurred at similar rates in both groups. The addition of PERT did not lead to an increase in adverse events.
Outcome measures
The primary outcome measures were changes in body weight and improvement in nutritional status (PNI) following the introduction of pancreatic enzyme replacement therapy (PERT). Secondary outcomes included overall survival (OS), chemotherapy continuation rate, and changes in tumor markers (CEA, CA19-9).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 31 | Day |
Other
Other related information
Single center, open-label, prospective cohort study. Between May 12, 2020, and December 31, 2022, consecutive patients with unresectable pancreatic cancer who met inclusion criteria.
Management information
Registered date
| 2020 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046034
