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The effect of oral nutrition supplement combined with health education on the weight of patients with gastric carcinoma underwent chemotherapy: a multi-center, open-label, randomized controlled clinical trial

The effect of oral nutrition supplement combined with health education on the weight of patients with gastric carcinoma underwent chemotherapy: a multi-center, open-label, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080757
Enrollment
Unknown
Registered
2024-02-06
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Experimental group:Oral nutrition supplement+ Health education
Control group:Health education

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Adult patients diagnosed with gastric cancer who have undergone radical surgery, without distant metastasis, and are scheduled to receive chemotherapy. (2) Nutritional supplement can be taken by mouth and there are no relevant contraindications. (3) Informed consent of the patient or guardian.

Exclusion criteria

Exclusion criteria: (1) There are contraindications to oral feeding or enteral nutrition. (2) Allergy to enteral nutrition-related ingredients. (3) Radiotherapy, chemotherapy or immunotherapy within 2 months prior to participation in the study. (4) Receipt of other types of enteral nutrition within 2 weeks prior to participation in the study. (5) Chronic renal insufficiency (glomerular filtration rate = 60 mL/min per 1.73 m2). (6) Combined with other immune diseases such as systemic lupus erythematosus, rheumatoid, etc. (7) Combined with hematologic tumors. (8) Combined with other malignant tumors. (9) Severe malnutrition (BMI<16.0 kg/m2) prior to participation in the study. (10) Severe hypoproteinemia (albumin<25g/L) before participating in the study. (11) Pregnancy. (12) Other patients who are considered by the investigator to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Weight;

Secondary

MeasureTime frame
PG-SGA score;Muscle mass;Calf circumference;Grip;Chemotherapy tolerance and completion rate of chemotherapy drugs;

Countries

China

Contacts

Public ContactRenying Xu

Renji Hospital, Shanghai Jiaotong University School of Medicine

xurenying7465@126.com+86 136 3630 4946

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026