UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052546 |
|---|---|
| Receipt number | R000059953 |
| Scientific Title | Phase II trial to evaluate the feasibility of preoperative weight loss program for obese patients with gastric cancer |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2025/04/23 12:07:09 |
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Basic information
Public title
Phase II trial to evaluate the feasibility of preoperative weight loss program for obese patients with gastric cancer
Acronym
Phase II trial to evaluate the feasibility of preoperative weight loss program
Scientific Title
Phase II trial to evaluate the feasibility of preoperative weight loss program for obese patients with gastric cancer
Scientific Title:Acronym
Phase II trial to evaluate the feasibility of preoperative weight loss program
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A phase II trial will explore the feasibility of a preoperative weight loss program using a formula diet for obese patients undergoing elective gastrectomy for gastric cancer.
Basic objectives2
Others
Basic objectives -Others
feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of weight loss program completed
Key secondary outcomes
Percentage of adverse events in the weight loss program, weight change before and after the intervention, changes in body composition, rate of weight loss and changes in body composition (lean body mass, fat mass) at 1, 3, and 6 months after surgery, energy and protein intake per week from the intervention, incidence of postoperative complications, operating time, intraoperative blood loss, prealbumin levels before and after intervention, postoperative inflammatory status
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Replace regular meals with formula meals
3 Group; once daily replacement, twice daily, three times daily
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Gastric adenocarcinoma is diagnosed histologically.
2) Patients must have cStage I-III gastric cancer that is expected to be amenable to radical (R0) resection.
3) Male and female patients aged 20 years or older but less than 80 years at the time of enrollment.
4) Body mass index of 25 kg/m2 or more.
5) PS: ECOG performance status score 0-2.
6) Patients are scheduled to undergo elective surgery.
7) Patients must be free of complications such as tetraplegia and have no limitation of activity.
8) Patients have not been previously treated for gastric cancer. However, endoscopic treatment is acceptable.
9) No preoperative treatment for gastric cancer.
10) Main organ function is preserved and the patient is judged to be operable.
11) Informed consent to participate in the study has been obtained from the patient.
Key exclusion criteria
None of the following apply.
1) The patient is scheduled to undergo simultaneous resection for multiple cancers.
2) The patient has preoperative severe malnutrition or requires preoperative tube feeding.
3) The patient is undergoing emergency surgery.
4) The patient has been diagnosed with dementia.
5) The patient has psychosis or psychiatric symptoms.
6) Patient has a history of allergy to formula diets.
7) Patient is taking oral nutritional supplements or supplements.
8) Patient has a condition that the study physician deems inappropriate.
9) Patient does not give consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Souya |
| Middle name | |
| Last name | Nunobe |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Gastric Surgery, Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
03-3520-0111
souya.nunobe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Matsui |
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Gastric Surgery, Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
03-3520-0111
Homepage URL
ryota.matsui@jfcr.or.jp
Sponsor or person
Institute
Gastric Surgery, Department of Gastroenterological Surgery, The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sunnyhealth Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address
3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
Tel
03-3520-0111
ryota.matsui@jfcr.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
| 2023 | Year | 10 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 19 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059953
