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Not Yet Recruiting NCT07759258

Plasma GLP-2 Dynamics and Acute Radiation Enteritis After Abdominopelvic Radiotherapy

Conditions: Radiation Enteritis

Sex: All
Ages: 18 Years – 75 Years
Enrollment: 50
Sponsor: Wang Xinying

Summary

This prospective observational study will enroll 50 adults who are scheduled to receive radiotherapy to the abdomen or pelvis. The study will not assign any additional treatment or change routine clinical care. Residual blood samples from routine clinical testing will be collected before radiotherapy, at the end of radiotherapy, and one month after radiotherapy to measure plasma glucagon-like peptide-2 (GLP-2). Participants will be followed for gastrointestinal symptoms and the occurrence and severity of acute radiation enteritis. Researchers will compare GLP-2 levels and changes between participants who develop acute radiation enteritis and those who do not. The study will also examine the associations of GLP-2 with markers of intestinal barrier injury and inflammation, radiotherapy dose parameters, nutritional status, and quality of life. The aim is to explore whether plasma GLP-2 may help assess the risk and severity of acute radiation enteritis.

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria: 1. Age 18 to 75 years. 2. Diagnosed with a malignancy and scheduled to receive abdominopelvic radiotherapy. 3. No active enteritis or moderate-to-severe diarrhea before radiotherapy. 4. Expected to complete the planned course of radiotherapy and the 1-month post-radiotherapy follow-up. 5. Able to complete clinical data collection, gastrointestinal symptom assessment, nutritional assessment, quality-of-life assessment, and collection of residual peripheral venous blood samples from routine clinical testing. 6. Willing to participate and able to provide written informed consent. Exclusion Criteria: 1. Moderate-to-severe diarrhea, active inflammatory bowel disease, intestinal obstruction, short bowel syndrome, or severe malabsorption before radiotherapy. 2. Previous radiotherapy to the same abdominopelvic region. 3. Severe cardiac, hepatic, or renal failure. 4. Active infection, severe systemic inflammatory response, or active autoimmune disease. 5. Receipt during the study of treatments considered by the investigator to substantially affect intestinal hormones, inflammatory markers, or intestinal barrier function and interfere with the study results. 6. Pregnancy or breastfeeding. 7. Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07759258). StuddyBuddy aggregates publicly available trial information.