Randomized comparative study to examine the effect of early exercise and parenteral nutrition therapy intervention on lean body mass loss after gastrectomy

Randomized comparative study to examine the effect of early exercise and parenteral nutrition therapy intervention on lean body mass loss after gastrectomy - Randomized comparative study on exercise and parenteral nutrition interventions after gastrectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042579

Enrollment

Registered

2020-11-30

Start date

2020-12-10

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

Gastric Cancer

Interventions

Amino acid-containing infusion is administered from 1st to 5th day after surgery. Rehabilitation is carried out every day in line with behavior objective from the next day after surgery. Maintenanc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proven adenocarcinoma of the stomach. 3) Clinical stage I-IVA gastric cancer that is expected to be curative (R0) resection. 4) PS: ECOG performance status score 0-2. 5) Planned surgery and no restriction on the procedure of gastrectomy.

Exclusion criteria

Exclusion criteria: 1) Synchronous cancer 2) History of gastric cancer treatment (excluding endoscopic treatment) 3) Preoperative chemotherapy 4) Emergency surgery. 5) Surgical findings showing R1 or R2 resection. 6) Severe heart , lung , liver and kidney disorder. 7) Activity restrictions due to complications such as quadriplegia. 8) Patients with thrombosis. 9) Hypersensitivity to eggs, soybeans, and thiamine chloride hydrochloride. 10) Taking insulin or warfarin. 11) Taking oral nutritional supplements and supplements (containing leucine). 12) Dementia, psychosis or psychiatric symptoms. 13) Others that the investigator considers inappropriate for participating in the exam

Design outcomes

Primary

Measure	Time frame
Percentage of lean body mass loss on 7 days after gastrectomy.	—

Secondary

Measure	Time frame
1) Percentage of lean body mass loss on 1 month and 3 months after gastrectomy 2) Changes of body weight, body composition (lean body mass / skeletal muscle mass / muscle mass / fat mass), and skeletal muscle index up to 1 year after surgery 3) Changes in walking speed, grip strength, and 5 times chair standing test up to 1 year after surgery 4) Incidence of postoperative complications 5) Postoperative inflammatory condition 6) Changes in nutrition index up to 1 year after surgery 7) Energy intake up to 1 year after surgery 8) Postoperative exercise compliance 9) Postoperative chemotherapy compliance	—

Measure

Time frame

1) Percentage of lean body mass loss on 1 month and 3 months after gastrectomy 2) Changes of body weight, body composition (lean body mass / skeletal muscle mass / muscle mass / fat mass), and skeletal muscle index up to 1 year after surgery 3) Changes in walking speed, grip strength, and 5 times chair standing test up to 1 year after surgery 4) Incidence of postoperative complications 5) Postoperative inflammatory condition 6) Changes in nutrition index up to 1 year after surgery 7) Energy intake up to 1 year after surgery 8) Postoperative exercise compliance 9) Postoperative chemotherapy compliance

—

Countries

Japan

Contacts

Public ContactMikiko Sakuraya

Kitasato University School of medicine Department of Upper Gastrointestinal Surgery

mikiko-mito@rg7.so-net.ne.jp0427788111

Outcome results

None listed

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