Multicenter randomized controlled trial comparing intensive nutritional support versus conventional nutritional support for gastric cancer patients who underwent gastric resection.

Multicenter randomized controlled trial comparing intensive nutritional support versus conventional nutritional support for gastric cancer patients who underwent radical gastrectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0003717

Enrollment

Registered

2019-04-04

Start date

2019-04-01

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Conventional nutritional support group 1. No preoperative nutritional therapies are performed. 2. If there is no postoperative complication, water intake begins between 1-4 days after surgery,

of the daily requirement. 5.Insert a periperally inserted central catheter (PICC) at discharge.After discharge, the home nurse will administrat parenteral nutritional supplement four times a week via

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients with stomach cancer Diagnosed by biopsy. (2)Patients with pre-operative body mass index greater than 23.5 kg / m2 (3)ECOG(Eastern Cooperative Oncology Group) performance is 0 or 1 (4)ASA(American Society of Anesthesiologist) score class are between I-III (5)On pre-operative CT(Computed Tomography) examinations, patients who were found to be able to undergo curative gastrectomy without any other organs except spleen (6)Patients scheduled for total gastrectomy or subtotal gastrectomy (7)Patients living in areas where home nursing is available (8)Patients who signed written consent form to participate in this study according to their free will

Exclusion criteria

Exclusion criteria: (1)Patient with gastric outlet obstruction (2)Patients scheduled for pylorus-preserving gastrectomy or proximal gastrectomy (3)Patients scheduled for resection of other organs (ovaries, adrenals, small intestine, etc.) (4)Patients with Siewert type 1 esophagogastric juctional cancer. (5)Patients with other organ cancer history within 5 years before surgery, or with present cancers of other organ (6)Patients who have been treated with systemic inflammatory disease or who are currently being treated (7)Patients with a history of gastrectomy

Design outcomes

Primary

Measure	Time frame
Percentage of weight loss	—

Secondary

Measure	Time frame
Percentage of weight loss;Change in body mass index;Percentage of underweight patients (body mass index <18.5 kg / m2);Changes in body composition;hemoglobin, albumin, ferritin, transferrin, folate, vitamin B12, calcium, phosphorus, vitamin D, neutrophil count, lymphocyte count;Changes in quality of life;Compliance with postoperative chemotherapy in patients with advanced gastric cancer;Complication rate, mortality rate	—

Measure

Time frame

Percentage of weight loss;Change in body mass index;Percentage of underweight patients (body mass index <18.5 kg / m2);Changes in body composition;hemoglobin, albumin, ferritin, transferrin, folate, vitamin B12, calcium, phosphorus, vitamin D, neutrophil count, lymphocyte count;Changes in quality of life;Compliance with postoperative chemotherapy in patients with advanced gastric cancer;Complication rate, mortality rate

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Countries

Korea, Republic of

Contacts

Public ContactYoungsuk Park

Seoul National University Bundang Hospital

youngsukmd@gmail.com+82-31-787-7099

Outcome results