NCT06098404

Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to characterize the microbiome and assess fatigue and cognition of patients with cancer undergoing standard of care treatment.

Detailed description

Cancer-related fatigue is experienced by nearly all patients during treatment, and cancer-related cognitive impairment (CRCI), which is a decrease in neurocognitive functioning that can be caused by cancer or its treatment, is present in up to ¾ of patients during treatment. Fatigue and CRCI have both been linked to the composition of the gut microbiome in cancer patients. CRCI is often reported as one of the most debilitating and life-altering aspects of cancer and treatment. Although CRCI is widely reported in patients with a variety of cancers and undergoing a variety of treatments, it is not clear if the mechanisms leading to symptoms are the same throughout. Using identical methods to monitor CRCI symptoms and microbial dysbiosis in a cross-section of various cancers, cancer stages, and treatments, can help to identify commonalities associated with symptoms. Specific Aims Specific Aim 1: Characterize the microbiome of cancer patients and compare to healthy control subjects from previous studies. Specific Aim 2: Assess fatigue in cancer patients and determine associations with composition of the gut microbiome.

Conditions

• Cancer

Timeline

• Start date: 2024-03-04
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-10-24
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States