UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028659 |
|---|---|
| Receipt number | R000032805 |
| Scientific Title | Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2026/08/28 13:51:20 |
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Basic information
Public title
Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer
Acronym
Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer
Scientific Title
Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer
Scientific Title:Acronym
Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of elemental diet during chemotherapy in patients with unresectable advanced pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival
Key secondary outcomes
Body weight, body composition, Plasma protein, CA 19-9, ECOG PS, QOL, Adverse events and tolerability of chemotherapy, Progression-free survival (PFS), Dietary Intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients administered elemental diet (1-2 packs per a day) for 3 month during chemotherapy
Interventions/Control_2
Patients administer chemotherapy without nutritional therapy
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 receiving chemotherapy for unresectable advance pancreatic cancer.
Patients gave a consent to participate in the study.
Key exclusion criteria
1. Age under 20 years
2. Allergy to Elental
3. Sever diabetes
4. Pregnant or breastfeeding women
5. Patients with amino acid disorder
6. Patients whom physician considered unqualifiable
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Iwashita |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu 501-1194
TEL
058-230-6308
takuji@w7.dion.ne.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Uemura |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu 501-1194
TEL
058-230-6308
Homepage URL
ueshin550621@gmail.com
Sponsor or person
Institute
First Dept. of Internal Medicine, Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
First Dept. of Internal Medicine, Gifu University Hospital
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
Gifu University Hospital Independent Ethics Committee
Address
1-1 Yanagido, Gifu
Tel
058-230-6059
gjme00004@jim.gifu-u.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
| 2017 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/41794391/
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/41794391/
Number of participants that the trial has enrolled
60
Results
Early ED supplementation during chemotherapy was associated with preserved nutritional status, improved treatment response, and prolonged overall survival in patients with advanced pancreatic cancer. These findings suggest that ED may serve as a potentially effective adjunct to systemic therapy. Larger multicenter randomized trials are warranted to confirm these results and further elucidate the underlying mechanisms.
Results date posted
| 2026 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients were enrolled in the study if they met the following eligibility criteria:untreated and pathologically diagnosed with unresectable pancreatic cancer (clinical stage III or IV, according to the TNM classification, 8th edition) and scheduled for chemotherapy; age >20 years; ECOG performance status of 0 or 1;adequate hepatic, renal, and bone marrow reserves; capable of oral intake; life expectancy of greater than two months; capable of providing written informed consent for the study. Exclusion criteria were set to obvious infection and fever up (>38C); serious complications (cardiac disease, bleeding tendency, uncontrolled diabetes, etc.); active overlapping cancer (disease-free for less than 5 years), symptomatic brain metastases; Pleural effusion or ascites requiring treatment; motor paralysis or peripheral neurological symptoms; history of hypersensitivity to any ingredient of ED; pregnant or lactating women; amino acid metabolism abnormalities; inappropriate by the study physician.
Participant flow
From July 2017 to March 2022, 60 patients who received chemotherapy for unresectable pancreatic cancer were assigned for eligibility, and all of the patients were enrolled in this study. Patients were randomly assigned to either the EI group (n = 30) or the ND group (n = 30). Three patients in the EI group could not complete the study due to withdrawal from participation and were excluded from further analysis. The final analysis included 27 patients in the EI group and 30 in the ND group.
Adverse events
There were no significant differences in overall adverse event rates for either all grades or grade >3 toxicities. Non-hematologic adverse events that could influence nutritional status, such as anorexia, vomiting, and diarrhea, also did not differ significantly between the EI and ND groups. Diarrhea and other gastrointestinal symptoms did not lead to discontinuation of ED in any patient. HbA1c and random blood glucose were evaluated at baseline and at 2 months. Among patients with preexisting diabetes (n=8 in the EI group and n=14 in the ND group, p=0.276), all were receiving antidiabetic treatment (oral agents and/or insulin), and there were no significant changes in HbA1c or random blood glucose over this period in either group. No clinically relevant worsening of diabetes requiring modification or discontinuation of ED was observed.
Outcome measures
The primary endpoint of this study was the survival rate at one year and OS. The secondary endpoints were PFS, response rate, adverse event rate, and changes in nutritional parameters.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 14 | Day |
Last modified on
| 2026 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032805
