NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051190015

Registered date:09/05/2019

Randomized trial of Exercise and NUtritional prehabilitation for Elderly Gastric Cancer patients

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedGastric cancer
Date of first enrollment24/05/2019
Target sample size110
Countries of recruitment
Study typeInterventional
Intervention(s)Patients who assigned to control group does not receive any preoperative intervention. Preoperative exercise and nutritional prehabilitation are as follows; Exercise: aerobic exercise (1-hour walk) and muscle strengthening training using TheraBand with medium load. Nutritional support includes recommendation of 2 packs of HMB supplementation

Outcome(s)

Primary OutcomePercentage of change in skeletal muscle mass before surgery.
Secondary OutcomeRate of patients with sarcopenia after surgery Incidence of postoperative complications Postoperative hospital stay Induction rate of postoperative adjuvant chemotherapy Completion rate of postoperative adjuvant chemotherapy Prognosis Nutritional parameters (weight serum albumin level)

Key inclusion & exclusion criteria

Age minimum>= 65age old
Age maximum< 100age old
GenderBoth
Include criteria1. Histologically proven primary gastric adenocarcinoma 2. Aged 65 years or older 3. Patients who scheduled to undergo R0 gastrectomy for gastric cancer(open, laparoscopic, robotic) 4. PS 0-2 5. possible to oral intake 6. adequate organ function 7. Written informed consent
Exclude criteria1.Allergy for HMB/Arg/Glu 2.Multiple active cancer with disease-free period less than 5 year, except carcinoma in situ or intra-mucosal disease cured by local therapy. 3.Implementation of pace maker 4.Inappropriate for enrollment judged by physician.

Related Information

Contact

Public contact
Name Naoki Shinnno
Address 3-1-69 Otemae, Chuo-ku, Osaka Osaka Japan 541-8567
Telephone +81-6-6945-1181
E-mail sinno-na@mc.pref.osaka.jp
Affiliation Department of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institute
Scientific contact
Name Naoki Shinno
Address 3-1-69 Otemae, Chuo-ku, Osaka Osaka Japan 541-8567
Telephone +81-6-6945-1181
E-mail sinno-na@mc.pref.osaka.jp
Affiliation Department of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institute