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Phase II trial to evaluate the feasibility of preoperative weight loss program for obese patients with gastric cancer

Not Applicable
Conditions
Gastric cancer
Registration Number
JPRN-UMIN000052546
Lead Sponsor
Gastric Surgery, Department of Gastroenterological Surgery, The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of weight loss program completed
Secondary Outcome Measures
NameTimeMethod
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
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