Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study

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

Study Overview

• Status: Recruiting
• Conditions: Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Kristen McGovern, PhD; Phone Number: 409-772-8126; Email: kamcgove@utmb.edu
• Study Contact Backup: Name: Kate Randolph, BS; Phone Number: 409-223-7891; Email: kmrandol@utmb.edu

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • Recruiting
      • The University of Texas Medical Branch
      • Contact: Kate Randolph, BS; Phone Number: 409-223-7891; Email: kmrandol@utmb.edu
      • Principal Investigator: Melinda Sheffield-Moore, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected from community cancer clinics

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cancer Patients; Patients diagnosed with cancer undergoing standard of care treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of fecal microbiome using molecular methods at baseline	Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR at baseline	Baseline
Characterization of fecal microbiome using molecular methods at 6 months	Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR after 6 months of standard of care treatment.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Function as measured by Montreal Cognitive Assessment at baseline	The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA-BLIND v8.1 will be used in this study as it can be administered in person as well as over the telephone. The MoCA-BLIND consists of 9 questions with the following subcategories: memory, attention, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. The MoCA will be administered by a certified tester at enrollment. Scores range from 0 to 22, higher score being a better outcome.	Baseline
Cognitive Function as measured by Montreal Cognitive Assessment at 6 months	The Montreal Cognitive Assessment (MoCA) is a rapid assessment of cognition. The MoCA-BLIND v8.2 will be used in this study as it can be administered in person as well as over the telephone. The MoCA-BLIND consists of 9 questions with the following subcategories: memory, attention, language, abstraction, delayed recall and orientation. The MoCA has been used extensively to detect cognitive impairment in many conditions, including head trauma. The MoCA will be administered by a certified tester at enrollment. Scores range from 0 to 22, higher score being a better outcome. The MoCA will be performed after 6 months of standard of care treatment.	6 months
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline	The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition. There are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition.	Baseline
Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months	The Fatigue and Altered Cognition Scale (FACS) is a joint project from University of Texas Medical Branch and Texas A&M University. The FACS is a 20 question assessment designed to access perceived fatigue and cognition. There are 2 subscales used to calculate a total score. The subscales are: Fatigue and Altered Cognition. The total score is calculated by adding the subscales together. The range of the total score is 0-100, with a higher score indicating more fatigue and altered cognition. The FACS will be performed after 6 months of standard of care treatment.	6 months
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline	The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).	Baseline
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at 6 months.	The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome). The GSRS will be performed after 6 months of standard of care treatment.	6 months

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Melinda Sheffield-Moore, PhD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Microbiome; Fatigue; Cognition
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Fatigue
• Other Study ID Numbers: 23-0289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No