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Dynamic changes of body composition and toxic side effects in patients with gastric cancer treated with SOX/XELOX chemotherapy under the background of active nutritional intervention

Dynamic changes of body composition and toxic side effects in patients with gastric cancer treated with SOX/XELOX chemotherapy under the background of active nutritional intervention

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071748
Enrollment
Unknown
Registered
2023-05-24
Start date
2023-05-26
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Gastric cancer

Interventions

Group A:Active nutritional intervention

Sponsors

Ordos Central Hospital, Inner mongolia
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. For patients aged >= 18 years and with pathologically confirmed gastric cancer who were to receive sox or xelox chemotherapy, the dose intensity of oxaliplatin was 130 mg/m2, Ticeo 40mg/m2 or capecitabine 1000 mg/m2; 2. KPS score >= 70 points; 3. Before chemotherapy, there is no abnormality in liver and kidney function, blood routine and electrocardiogram. Blood test must meet the requirements of white blood cells > 3.5 x 10^9/L, neutrophils > 1.5 x 10^9/L, platelets > 85 x 10^9/L, alkaline phosphatase <= 2.5 times the upper limit of normal value. Serum alanine transferase (ALT) and aspartate aminotransferase (AST) <= 3 times the upper limit of normal, bilirubin <= 1.5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal. No other liver, kidney, blood system diseases; 4. Patients without contraindications to chemotherapy; 5. No intervention (such as surgery) to change body composition between CT scan and the start of chemotherapy; 6. Regular BIA and CT interviewers are acceptable; 7. Patients with no contraindications to moderate or medium-intensity exercise; 8. Informed consent and signed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with oxaliplatin, Tiggio and capecitabine allergies; 2. Patients who were in bed state and could not cooperate with nutritional assessment at the time of enrollment; 3. Persons with other severe wasting diseases; 4. Long-term use of hormones; 5. Spontaneous termination of antitumor therapy or failure to perform regular physical analysis or adverse reactions; 6. Bilirubin > 1.5 times the upper limit of normal, creatinine > 1.5 times the upper limit of normal; 7. Have contraindications to exercise.

Design outcomes

Primary

MeasureTime frame
bioelectrical impedance;muscle area of lumbar vertebra;Lean body mass;NRS2002 scale;PG-SGA scale;

Countries

China

Contacts

Public ContactLi Quanfu

Ordos Central Hospital, Inner Mongolia Ordos Clinical Medical College, Inner Mongolia Medical University

1729259137@qq.com+86 477 836 3279

Outcome results

None listed

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