sNEXTAC-GC ONE trial

JRCT ID: jRCTs041210144

Registered date:14/02/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer in elderly patients scheduled for gastrectomy
• Date of first enrollment: 15/03/2022
• Target sample size: 43
• Study type: Interventional

Intervention(s)

Cohort 1
Oral nutritional supplementation (Uplead, 400kcal/100ml) (12 weeks postoperatively)

Cohort 2
Nutrition and exercise program: A combination of oral nutritional supplementation (Uplead), nutritional counseling, home-based resistance training, and physical activity promotional counseling (15 weeks perioperatively)

Outcome(s)

Primary Outcome

Cohort 1
Postoperative compliance of Uplead

Cohort 2
Participation rate of nutrition and exercise program

Secondary Outcome

Cohort 1
1) Safety of Uplead
2) Efficacy of Uplead and dietary intake on postoperative outcomes
3) Patient survey on adverse events and preferences for Uplead

Cohort 2
1) Safety of nutrition and exercise program
2) Compliance of nutrition and exercise program
3) Incidence of sarcopenia and frail
4) Physical function
5) Body composition
6) Nutritional status
7) Health related quality of life (HR-QoL)
8) Postoperative complication
9) Compliance of adjuvant chemotherapy
10) Survival outcomes
11) Perioperative compliance of Uplead
12) Efficacy of Uplead on postoperative outcomes
13) Patient survey on adverse events and preferences for Uplead

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically proven gastric cancer by endoscopic biopsy.
2) Gastric cancer without distant metastasis or invasion of other organs.
3) Planned curative gastrectomy for gastric cancer.
4) Aged 65 years old or older.
5) Written informed consent.

Exclude criteria

1) Planned neoadjuvant chemotherapy for gastric cancer.
2) Need assistance with eating, bathing, dressing, or moving.
3) Severe cardiopulmonary, musculoskeletal, or neurological diseases.
4) Severe mental disease.
5) Allergy for milk or gelatin

Related Information

• Primary Sponsor: Bando Etsuro
• Source(s) of Monetary Support: Terumo corporation