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Trial Title:
Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
NCT ID:
NCT06098404
Condition:
Cancer
Conditions: Official terms:
Dysbiosis
Conditions: Keywords:
Microbiome
Fatigue
Cognition
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Subjects will be selected from community cancer clinics
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Current diagnosis of cancer.
2. Ages 18 and over.
3. Has access to a device (smart phone, computer, tablet) with internet access.
4. Participant is willing and able to give informed consent for participation in the
study.
Exclusion Criteria:
1. Females who are pregnant or lactating.
2. Other medical conditions or medications deemed exclusionary by the study
investigators.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas Medical Branch
Address:
City:
Galveston
Zip:
77555
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kate Randolph, BS
Phone:
409-223-7891
Email:
kmrandol@utmb.edu
Investigator:
Last name:
Melinda Sheffield-Moore, PhD
Email:
Principal Investigator
Start date:
March 4, 2024
Completion date:
October 2025
Lead sponsor:
Agency:
The University of Texas Medical Branch, Galveston
Agency class:
Other
Source:
The University of Texas Medical Branch, Galveston
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06098404
