Clinical study on the usefulness of preoperative Short-TErm Program for Nutrition and Exercise Trial (STEP-NEXT) for esophagectomy

JRCT ID: jRCTs041190075

Registered date:01/11/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 10/12/2019
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Patients take protein 40g/day (branched-chain amino acid; BCAA 3g or more) from 2weeks before esophagectomy in addition to normal nutritional guidance; ie, patients get protein 1.2g/kg/day or more and vitamin D 800 IU or more.
Patients perform weekly rehabilitation for 40 minutes and receive the guidance of exercise load on an outpatient basis in addition to the regular medical program.

Outcome(s)

• Primary Outcome: the AT value before and after this program

Secondary Outcome

Physical function at the time of provided informed consent, before surgery, and 1,3,6,12 months after esophagectomy.
InBody results at the time of provided informed consent, before surgery, and 1,3,6,12 months after esophagectomy.
Adverse events
Postoperative complications

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Aged 20 to 80
Patients who have been diagnosed with esophageal cancer and will undergo esophagectomy
ADL before treatment is independent

Exclude criteria

Allergy to gelatin, apple, orange, peach, banana, pineapple, and milk component
Planned to surgical treatment after an esophagectomy due to multiple primary cancer (head and neck cancer etc.)
Patients who have difficulty performing cardiopulmonary exercise testing
Patients who have some trouble with walking or performing tests by paralysis from cerebral vascular disorders
Patients with cardiovascular disease
Patients with a history of spinal cord damage or cervical cord damage.
Patients with serious liver dysfunction
Patients with serious renal dysfunction
Patients with stenosis of esophagus and who have difficulty taking supplement
Patients with diabetes and have difficulty treating blood glucose levels (HbA1c 8.0% or higher)

Related Information

• Primary Sponsor: Hiramatsu Yoshihiro