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NCT Number: NCT06098404

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location status: Recruiting

Location contact

Kate Randolph, BS

CONTACT

[email protected]

409-223-7891

Melinda Sheffield-Moore, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current diagnosis of cancer.
  • Ages 18 and over.
  • Has access to a device (smart phone, computer, tablet) with internet access.
  • Participant is willing and able to give informed consent for participation in the study.

Exclusion criteria

  • Females who are pregnant or lactating.
  • Other medical conditions or medications deemed exclusionary by the study investigators.

Treatment and study plan

Primary outcomes

  1. Characterization of fecal microbiome using molecular methods at baseline

    Time frame: Baseline

    Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for PCR at baseline

  2. Characterization of fecal microbiome using molecular methods at 6 months

    Time frame: 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.

Secondary outcomes

  1. Cognitive Function as measured by Montreal Cognitive Assessment at baseline

    Time frame: 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.

  2. Cognitive Function as measured by Montreal Cognitive Assessment at 6 months

    Time frame: 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.

  3. Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline

    Time frame: 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.

  4. Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at 6 months

    Time frame: 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.

  5. Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline

    Time frame: 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).

  6. Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at 6 months.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Randolph, BS

CONTACT

[email protected]

409-223-7891

Kristen McGovern, PhD

CONTACT

[email protected]

409-772-8126

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2023
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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