Plasma GLP-2 Dynamics and Acute Radiation Enteritis After Abdominopelvic Radiotherapy
ConditionRadiation Enteritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorWang Xinying
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 18 to 75 years.
Diagnosed with a malignancy and scheduled to receive abdominopelvic radiotherapy.
No active enteritis or moderate-to-severe diarrhea before radiotherapy.
Expected to complete the planned course of radiotherapy and the 1-month post-radiotherapy follow-up.
Disqualifiers
Moderate-to-severe diarrhea, active inflammatory bowel disease, intestinal obstruction, short bowel syndrome, or severe malabsorption before radiotherapy.
Previous radiotherapy to the same abdominopelvic region.
Severe cardiac, hepatic, or renal failure.
Active infection, severe systemic inflammatory response, or active autoimmune disease.
Trial population
The study population will consist of approximately 50 adults aged 18 to 75 years with malignant tumors who are scheduled to receive abdominopelvic radiotherapy at a single medical center. Eligible participants will be enrolled prospectively before radiotherapy and followed throughout radiotherapy until 1 month after treatment completion. Participants will receive routine clinical care without any study-assigned therapeutic intervention. Residual blood samples from routine clinical testing and relevant clinical, symptom, nutritional, radiotherapy, and quality-of-life data will be collected.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Abdominopelvic Radiotherapy
RadiationParticipants will receive abdominopelvic radiotherapy according to routine clinical care. The study will not assign or modify the radiotherapy regimen. Radiotherapy-related information, including the treatment site, total dose, dose per fraction, number of fractions, treatment field, and dose parameters for organs at risk, will be recorded.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in Plasma GLP-2 Concentration Over Time
Plasma glucagon-like peptide-2 (GLP-2) concentration will be measured using an enzyme-linked immunosorbent assay or another validated quantitative method. Absolute GLP-2 concentrations and changes from the pre-radiotherapy level will be compared between participants who develop acute radiation enteritis and those who do not.
Time frame
Baseline (before initiation of radiotherapy), within 24 hours after completion of the final radiotherapy session, and 1 month after completion of radiotherapyLocations
Sponsors and contacts
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Wang Xinying
Lead sponsor
Jinling Hospital, China
Sponsor institution
Source ClinicalTrials.gov
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