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

JRCT ID: jRCTs051190015

Registered date:09/05/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 24/05/2019
• Target sample size: 110
• Study type: Interventional

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 Outcome: Percentage of change in skeletal muscle mass before surgery.

Secondary Outcome

Rate 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
• Gender: Both

Include criteria

1. 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 criteria

1.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

• Primary Sponsor: Masuike Yasunori