UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043223 |
|---|---|
| Receipt number | R000049263 |
| Scientific Title | A comparative study on the long-term results of nutritional support using enteral nutrition for patients undergoing chemotherapy for unresectable pancreatic and biliary tract cancer |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2025/05/02 12:37:37 |
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Basic information
Public title
A comparative study on the long-term results of nutritional support using enteral nutrition for patients undergoing chemotherapy for unresectable pancreatic and biliary tract cancer
Acronym
A Comparative Study on the long-Term Outcome of Enteral Nutrition for Patients Receiving Chemotherapy for Pancreatic and Biliary Tract Cancer
Scientific Title
A comparative study on the long-term results of nutritional support using enteral nutrition for patients undergoing chemotherapy for unresectable pancreatic and biliary tract cancer
Scientific Title:Acronym
A Comparative Study on the long-Term Outcome of Enteral Nutrition for Patients Receiving Chemotherapy for Pancreatic and Biliary Tract Cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer/Biliary cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the long-term effects of enteral nutrition therapy on tumor immunity and skeletal muscle mass in patients treated with chemotherapy for unresectable pancreatic or cholangiocarcinoma with those who do not receive enteral nutrition.
In addition to the endpoints of this protocol, the following endpoints will be evaluated: (1) chemotherapy response rate, (2) tolerability (chemotherapy adverse event rate, chemotherapy continuation rate, QOL score), and (3) overall survival (OS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
skeletal muscle mass
Key secondary outcomes
Weight, chemotherapy response rate, chemotherapy tolerability (adverse event rate, chemotherapy continuation rate), overall survival, blood sampling data (blood EPA concentration, EPA/AA ratio, Glasgow prognostic score (CRP, Alb), serum proteins (TP, retinol binding protein (RBP), prealbumin), white blood cells (neutrophils), IL-6, NK cell activity White blood cells (neutrophils), IL-6, NK cell activity, HbA1c (pancreatic cancer only), CEA, CA19-9), QOL score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The intervention group received at least 2 packs (375 mL/600 kcal) of Inolas (pharmaceutical product) per day, and the following endpoints were tested before and every 4 weeks after administration (start of the study)
Interventions/Control_2
The control group will not receive any therapeutic intervention using enteral nutrition and will be surveyed for the same endpoints every 4 weeks during the observation period.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable pancreatic or cbiliary cancer who are undergoing chemotherapy and have given consent for this clinical trial.
Key exclusion criteria
1 PS 3,4 (according to ECOG criteria)
2 Difficulty in oral intake
3 Active infectious disease
4 History of hypersensitivity to administered drugs (or equivalent supplements) or milk protein (Inolas contains milk protein)
5 Poorly controlled diabetes mellitus (HbA1c 7.0percents or higher)
6 Duplication of cancer outside the biliary-pancreatic region
7 Receiving warfarin
8 Plt<100,000
9 Patients with severe hepatic or renal impairment
10 Inborn error of amino acid metabolism
11 In case the attending physician deems it inappropriate
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Abe |
Organization
Department of Surgery, The Jikei University School of Medicine
Division name
Department of Surgery
Zip code
1058461
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan.
TEL
0334331111
kyouheiabe2010@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Abe |
Organization
The Jikei University School of Medicine
Division name
Department of Surgery
Zip code
1058461
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan.
TEL
0334331111
Homepage URL
kyouheiabe2010@yahoo.co.jp
Sponsor or person
Institute
The Jikei University School of Medicine
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
Department of Surgery, The Jikei University School of Medicine
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo 105-8461, Japan.
Tel
0334331111
kyouheiabe2010@yahoo.co.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
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000049263
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
82
Results
After 4 and 8 weeks of treatment, the intervention group showed significantly less skeletal muscle mass loss than the non-intervention group. Prealbumin and retinol-binding protein levels were significantly higher in the intervention group than in the non-intervention group at 4 and 8 weeks post-treatment.
Results date posted
| 2025 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients diagnosed with unresectable pancreatic and biliary tract cancer (including non-resected cases and postoperative recurrence, respectively) were recruited.
The chemotherapy regimens included fluorouracil/leucovorin plus irinotecan and oxaliplatin (FOLFIRINOX), gemcitabine plus cisplatin (GC), and gemcitabine plus TS1 (GS) for pancreatic cancer and GC, GS, and TS1 for biliary tract cancer.
Participant flow
This study was conducted between January 2019 and December 2022 at four Jikei University Hospitals and included 95 patients undergoing chemotherapy for unresectable pancreatic and biliary tract cancers, 82 of whom were included in the final analysis. Data on sex, age, BMI, diagnosis, history, and medical history were collected from the medical records. Variables related to chemotherapy, such as date and details of administration, were also investigated. Various parameters (body weight, skeletal muscle, and blood test) were measured at the start of the study, and the patients were randomly divided into two groups: Inolus (omega-3 fatty acid fortified enteral nutrition, containing 2 g of omega-3 fatty acids; Otsuka Pharmaceutical, Tokyo, Japan) intervention group and non-intervention group using random number tables. Post-test results were analyzed prospectively.
Adverse events
There were no cases of adverse events.
Outcome measures
The primary endpoints were skeletal muscle mass and chemotherapy continuation rate (number of times chemotherapy was skipped because of neutropenia 2 months before and 2 months after study entry). Secondary endpoints included body weight, blood draw data, prealbumin (PA) and retinol-binding protein (RBP) as RTP, NK cell activity, blood eicosapentaenoic acid (EPA) concentration, neutrophils, carcinoembryonic antigen (CEA), and Hemoglobin A1c (HbA1c). The endpoints were examined at the first, second, and third months of the study. In both groups, chemotherapy was administered based on the dosage of the drug at the institution of observation as dose intensity (the ratio of the 2-month dosage to the standard dosage for each regimen). The number of skips in chemotherapy per month was assessed, and the number of skips in chemotherapy due to neutropenia or physical findings was counted 2 months before and 2 months after the intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 02 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049263
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/05/02 | ω3RCT研究計画書 kyoheiABE.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/05/03 | UMINファイル.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/05/03 | up症例umin.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/49263
