Skip to content

A prospective, randomized, controlled, multicenter clinical study to evaluate the effects of oral nutritional supplement on nutritional status and immunological function during adjuvant chemotherapy after surgical resection in patients with gastrointestinal cancer

A prospective, randomized, controlled, multicenter clinical study to evaluate the effects of oral nutritional supplement on nutritional status and immunological function during adjuvant chemotherapy after surgical resection in patients with gastrointestinal cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007300
Enrollment
Unknown
Registered
2015-10-23
Start date
2015-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

gastrointestinal cancer

Interventions

Experiment group:Ensure
Control group:conventional diet

Sponsors

ZhangChangHua
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Men or women patients aged 18~80 years; 2. Patients who have undergone surgical resection of gastrointestinal cancers 3 or 4 weeks ago, and the expectation of life is more than 6 months; 3. Post-operative pathologic pTNM staging: stage II or III gastric cancer or colorectal cancer (NCCN version 7); 4. Patients who will receive post-operative adjuvant chemotherapy; 5. Patients with malnutrition (BMI5 6. ECOG performance status (PS) score: 0-2; 7. Blood white cell count at 3500-12000/ul; neutrophil count at 2000/ul or above; hemoglobin at 9.0 g/dL or above, platelet at 100000/ul or above; total bilirubin, aspartate amino transferase (AST) and alanine amino transferase

Exclusion criteria

Exclusion criteria: 1. Participated other clinical trials within two months prior to the study; 2. Mental disorders and poor cooperation; 3. Patients who are unable to take oral diet; 4. Intestinal bleeding, serious malabsorption, serious short bowel syndrome or fistula with high excretion amount, and serious nausea and vomiting; 5. Patients who have combined serious cardiac diseases, diabetes mellitus, hyperlipemia, electrolyte disturbances, abnormal hepatic and renal functions, or patients who are considered not suitable for participating the study; 6. Patients who received parenteral and enteral nutrition within two weeks prior to screening; 7. Pregnancy or breastfeeding or plan to be pregnant within one year; 8. Not suitable for participating the study in the investigators opinion; 9. Patients who are allergic to milk or soybean protein; 10. Patients who may use other nutritional products during the study, such as protein powder, bovine colostrum etc. 11. Patients who are not willing to provide their informed consent form (ICF) or by their authorized representative;

Design outcomes

Secondary

MeasureTime frame
Nutritional indicators;Immunity indicators;Incidence of adverse reactions of chemotherapy;Quality of life score;Blood test;

Primary

MeasureTime frame
PG-SGA score;

Countries

China

Contacts

Public ContactZhang Changhua
zhchangh@mail.sysu.edu.cn+86 13678987415

Outcome results

None listed

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