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Phase III trial to evaluate the efficacy of nutrition and exercise intervention on lean body mass loss after gastrectomy for gastric cancer (NEx-RCT)-Open-label randomized trial

Phase III trial to evaluate the efficacy of nutrition and exercise intervention on lean body mass loss after gastrectomy for gastric cancer (NEx-RCT)-Open-label randomized trial - A phase III trial on nutrition and exercise intervention after gastrectomy (NEx-RCT)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042307
Enrollment
242
Registered
2020-10-31
Start date
2020-11-16
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

Oral supplementation of 1 pack of leucine rich amino acid supplement per day for 90 days from the 2nd day after surgery. Rehabilitation is carried out every day in line with behavior objective fro

Sponsors

Cancer Institute Hospital, Japanese Foundation for Cancer Research
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: i) Histologically proven adenocarcinoma of the stomach. ii) Clinical stage I-IVA gastric cancer that is expected to be R0 resection. iii) ECOG performance status 0-1. iv) Planned surgery and no restriction on the procedure of gastrectomy. v) Written informed consent.

Exclusion criteria

Exclusion criteria: i) Synchronous cancer ii) Severe heart and pulmonary disorder iii) Preoperative tube feeding is needed due to poor oral intake. iv) Allergic reaction to apple. v) Oral nutritional supplements are taken. vi) When the examining physician judges that she/he is not adequate for the study.

Design outcomes

Primary

MeasureTime frame
%lean body mass loss at 3 months after gastrectomy.

Secondary

MeasureTime frame
The change of body weight, body composition, walking speed, hand grip strength, 5-time chair stand test, nutritional index up to 1 year after surgery. Incidence of complication.

Countries

Japan

Contacts

Public ContactSatoshi Ida

Cancer Institute Hospital, Japanese Foundation for Cancer Research Department of Gastroenterological Surgery

satoshi.ida@jfcr.or.jp03-3520-0111

Outcome results

None listed

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