UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032291 |
|---|---|
| Receipt number | R000036822 |
| Scientific Title | Phase II trial to evaluate compliance of postoperative nutrition by Uplead in total gastrectomy for gastric cancer |
| Date of disclosure of the study information | 2018/04/17 |
| Last modified on | 2022/10/20 10:22:40 |
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Basic information
Public title
Phase II trial to evaluate compliance of postoperative nutrition by Uplead in total gastrectomy for gastric cancer
Acronym
Uplead trial
Scientific Title
Phase II trial to evaluate compliance of postoperative nutrition by Uplead in total gastrectomy for gastric cancer
Scientific Title:Acronym
Uplead trial
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of postoperative Uplead after total gastrectomy for gastric cancer case.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
compliance with supplementation
Key secondary outcomes
body weight and lean body mass reduction 1 month and 3 months after surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Supplementation of Uplead
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
i. Histologically proven adenocarcinoma of the stomach
ii.Clinical T1-T4a and no distant metastasis
iii.R0 resection is possible by open total gastrectomy
iv.Enough oral intake after sugery
v.Age ranging between 20 and more.
vi.ECOG performance status 0-1.
vii.Not cancer of the remnant stomach
viii.Suficient organ functions.
iv.Written informed consent.
Key exclusion criteria
i.Synchronous or metachronous cancer (synchronous multiple cancers in the stomach included).
ii.Active inflammation which requires systemic treatment
iii.Allergy for contents of Uplead
iv.Uncontrollable diabetes mellitus
v.Systemic treatment with corticosteroid
vi.Unstable angina or cardiac infarction within 6 months
vii.Pulmonary disorder under oxygen
viii.Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy.
ix.Mental disorders which may affect ability or willingness to provide informed consent or abide by the study protocol
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Takaki |
| Middle name | |
| Last name | Yoshikawa |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao Asahi Yokohama Kanagawa Japan
TEL
+81-45-520-2222
yoshikawat@kcch.jp
Public contact
Name of contact person
| 1st name | Takanobu |
| Middle name | |
| Last name | Yamada |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao Asahi Yokohama Kanagawa Japan
TEL
+81-45-520-2222
Homepage URL
tknbymd@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
non-profit organization KSATTS
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
Kanagawa Cancer Center
Address
1-1-2 Nakao Asahi Yokohama Kanagawa, Japan
Tel
0455202222
takay0218@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
| 2018 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00268-022-06639-1
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00268-022-06639-1
Number of participants that the trial has enrolled
35
Results
The median relative dose intensity was 25.8%(95& confidence interval 20.6-42.0). The median body weight loss at 1 and 3 months after srugery was 7.2% (3.2-13.9%)and 13.1%(2.5-20.4%) respectively.
Oral nutritional supplementation with a high-density liquid diet (Uplead(R)) was safely and administered but not feasible after total gastrectomy for gastric cancer.
Results date posted
| 2022 | Year | 10 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Four patients were judged to be ineligible: Two had peritoneal metastasis detected during operation, one had preoperative pneumonia, and one was allergic to UpLead(R). In addition, two patients could not start UpLead(R) due to anastomotic leakage.
Participant flow
Among 35 patients enrolled before surgery between April 2018 and December 2019, 29 patients who could initiate UpLead(R) after surgery were analyzed.
Adverse events
The remaining 22 patients completed 28 days of UpLead(R) intake, including temporary interruption, with no associated adverse events
Outcome measures
The median relative dose intensity was 25.8%(95& confidence interval 20.6-42.0). The median body weight loss at 1 and 3 months after srugery was 7.2% (3.2-13.9%)and 13.1%(2.5-20.4%) respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 17 | Day |
Last modified on
| 2022 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036822
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