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Multi-institutional prospective randomized clinical trial to explore efficacy of postoperative exercise and oral nutritional supplement (Rehadays) in total gastrectomy for gastric cancer

Multi-institutional prospective randomized clinical trial to explore efficacy of postoperative exercise and oral nutritional supplement (Rehadays) in total gastrectomy for gastric cancer - Randomized clinical trial to explore efficacy of postoperative exercise and oral nutritional supplement in total gastrectomy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032256
Enrollment
60
Registered
2018-07-01
Start date
2018-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

gastric cancer

Interventions

oral nutritional supplement In the exercise and nutritional support group, the patients drink 2 packs of oral nutritional supplements (Rehadays) per day between postoperative day (POD) 3 and 30. exe

Sponsors

Okayama University
Lead Sponsor
Kochi Health Sciences Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.gastric cancer patients who are planned to undergo total gastrectomy 2.patient's age is over than 20 years old 3.clinical stage 1, 2 or 3 and curative resection at the end of surgery 4.Eastern Cooperative Oncology Group performance status of 0, 1 5.ability for oral intake 6.Before participation, patients receive information about the study and provide their written consent

Exclusion criteria

Exclusion criteria: 1.diagnosis of other organ cancer 2.contraindications to Rehadays (allergy to milk or coffee) 3.active infection or inflamation 4.uncontrolled diabetes 5.pregnancy or intention for pregnancy 6.Immunodeficiency 7.clinically relevant cardiac or pulmonary disease 8.history of clinically relevant mental disorder or central nervous system disorder 9.Unsuitable patients for enrollment judged by the investigator

Design outcomes

Primary

MeasureTime frame
Body weight loss rate at 4-6 weeks after total gastrectomy

Secondary

MeasureTime frame
1.compliance with oral nutritional supplement 2.muscle mass loss rate 3.body composition change 4.nutrition related blood parameters (serum total protein, serum albumin, total cholesterol, total lymphocyte number, c-reactive protein, multifunctionality and exhaustion of lymphocyte) 5.postoperative complication 6.quolity of life 7.postoperative bodyweight and body composition changes at 3m, 6m and 12m. 8.compliance with adjuvant chemotherapy

Countries

Japan

Contacts

Public ContactSatoru Kikuchi

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Gastroenterological surgery

satorukc@okayama-u.ac.jp086-235-7257

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026