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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041190075
Enrollment
50
Registered
2019-11-01
Start date
2019-12-10
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

Esophageal cancer Esophageal cancer

Interventions

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 add
Nutrition therapy / exercise therapy

Sponsors

Hiramatsu Yoshihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion 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)

Design outcomes

Primary

MeasureTime frame
the AT value before and after this program

Secondary

MeasureTime frame
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

Contacts

Public ContactYoshihiro Hiramatsu

Hamamatsu University School of Medicine

hiramatu@hama-med.ac.jp+81-53-435-2427

Outcome results

None listed

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