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RecruitingObservational

Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study

NCT ID: NCT06098404Sponsor: The University of Texas Medical Branch, GalvestonLast updated: 2025-12-16

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.

Arms & interventions

Outcome measures

Primary

  • 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

    Time frame: 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.

    Time frame: 6 months

Secondary

  • Cognitive Function as measured by Montreal Cognitive Assessment at baseline

    Time frame: Baseline

  • Cognitive Function as measured by Montreal Cognitive Assessment at 6 months

    Time frame: 6 months

  • Fatigue and Cognition as measured by the Fatigue and Altered Cognition Scale at baseline

    Time frame: Baseline

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

    Time frame: 6 months

  • Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline

    Time frame: Baseline

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

    Time frame: 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

The University of Texas Medical Branch

Galveston, Texas, 77555

Recruiting
Kate Randolph, BS · Contact
409-223-7891kmrandol@utmb.edu
Melinda Sheffield-Moore, PhD · Principal Investigator
Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study | Cancerify