Exploring the link between gut microbiome and cancer-related fatigue and cognition
Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study
This study is trying to see if the bacteria in the gut of cancer patients affects their feelings of tiredness and problems with thinking while they are getting treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston Academic / other |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT06098404 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the gut microbiome and assess levels of fatigue and cognitive impairment in cancer patients undergoing standard treatment. It focuses on understanding the relationship between microbiome composition and symptoms of cancer-related cognitive impairment (CRCI) and fatigue, which are common and debilitating issues faced by cancer patients. By employing consistent methods to evaluate these symptoms across various cancer types and treatments, the study seeks to identify shared mechanisms that may contribute to these symptoms. The findings could provide insights into potential interventions to alleviate these challenges.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over who have a current diagnosis of cancer.
Not a fit: Patients who are pregnant or lactating, or those with other medical conditions that exclude them from participation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of fatigue and cognitive impairment in cancer patients.
How similar studies have performed: While the relationship between gut microbiome and cancer-related symptoms is being explored, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Galveston, Texas
- The University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Melinda Sheffield-Moore, PhD — University of Texas
- Study coordinator: Kate Randolph, BS
- Email: kmrandol@utmb.edu
- Phone: 409-223-7891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.