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Randomized controlled phase II clinical study of Individual or Conventional nutritional support for malnutrioned patients with malignant tumor of the gastrointestinal tract during the chemotherapy or radiotherapy

Randomized controlled phase II clinical study of Individual or Conventional nutritional support for malnutrioned patients with malignant tumor of the gastrointestinal tract during the chemotherapy or radiotherapy

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007328
Enrollment
Unknown
Registered
2015-05-23
Start date
2015-05-01
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

malnutrioned patients with malignant tumor of the gastrointestinal tract during the chemotherapy or radiotherapy

Interventions

experimental group:Individual nutritional support
control group:General nutrition support

Sponsors

West China Hospital Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age years 18-80;gastric adenocarcinoma and adenocarcinoma of esophagogastric junction patients with pathological staging >=3 after R0 radical correction(The seventh edition of AJCC staging III, II period gastric adenocarcinoma patients),agreeing to accept adjuvent chemotherapy or radiotherapy;colorectal adenocarcinoma patients with pathological staging >=3 after R0 radical correction(The seventh edition of AJCC staging III, II period colorectal adenocarcinoma patients), agreeing to accept adjuvent chemotherapy or radiotherapy; patients with unresectable advanced gastric cancer,agreeing to accept adjuvent chemotherapy or radiotherapy;atients with unresectable advanced colorectal cancer, agreeing to accept adjuvent chemotherapy or radiotherapy; ECOG score 0-2; PG-SGA score >=4; Laboratory test results two weeks before in the group should meet the following requirements: GRA >=1.0*10^9/L or PLT/BPC >=100*10^9/L, TB =30 mL/min, coagulative function is normal; electrocardiogram is normal; expected survival >=6 months; signing the informed conse.

Exclusion criteria

Exclusion criteria: Patients with gastrointestinal dysfunction, intestinal obstruction, pyloric obstruction;patients with acute gastrointestinal hemorrhage; patients being allergic to animal protein or intravenous nutrition;patients with any severe case or uncontrolled systemic disease (e.g: unstable or decompensational aspiratory, cardiac, hepatic, renal diseases, infectious diseases, uncontrolled hypertension, severe arrhythmia, uncontrolled diabetes, active hemorrhage; patients with cardiac pacemaker; patients taking oral drugs to strengthen muscles; women with pregnancy or under lactation, women without contraception or with positive pregnancy test before treatment; patients having history of malignant tumor in 5 years, excepted well-treated basal cell carcinoma, cutaneous squamous cell carcinoma and cancer in situ.

Design outcomes

Primary

MeasureTime frame
Weight change rate;

Secondary

MeasureTime frame
QOL;BMI;os;PFS;DFS;PG-SGA scores;AE;BCM;

Countries

China

Contacts

Public ContactLi Qiu
fbqiu9@163.com+86 028 85423609

Outcome results

None listed

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