Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors

Advances in medical care have significantly improved survival among children with cancer. In China, the 5-year survival rate has reached 71.9%. Despite these improvements, many survivors continue to experience multiple co-occurring symptoms, such as fatigue, pain, sleep disturbance, and depression, which may adversely affect their quality of life. These symptoms often occur together as symptom clusters and may reflect shared underlying biological mechanisms. This study aims to characterize symptom clusters among childhood cancer survivors and to explore their potential biological basis. Participants will complete questionnaire assessments at multiple time points to evaluate symptom patterns and changes over time. In addition, stool samples will be collected to analyze gut microbiota composition and metabolite profiles. The study will examine the associations between symptom clusters and gut microbiota-metabolite features. Findings from this study are expected to improve understanding of symptom burden in childhood cancer survivors and to provide evidence for the development of targeted symptom management strategies.

NCT Number	NCT07450872
Lead Sponsor	The Children's Hospital of Zhejiang University School of Medicine Collaborators: Fujian Maternity and Child Health Hospital, Jiangxi Province Children's Hospital
Conditions	Cancer, Glioma, Leukemia (Both ALL and AML)
Enrollment	600 participants
Start Date	2026-01-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-05