Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT06098404
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2023-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
Sponsor:
The University of Texas Medical Branch, Galveston
Organization:
Study Overview
Official Title:
Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: