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Correlates of CRCI and Gut Microbiome Dysbiosis; a Pilot Study

NCT ID: NCT06098404

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-04

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer Patients

Patients diagnosed with cancer undergoing standard of care treatment.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melinda Sheffield-Moore, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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The University of Texas Medical Branch

Galveston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kate Randolph, BS

Role: CONTACT

[email protected]
409-223-7891

Kristen McGovern, PhD

Role: CONTACT

[email protected]
409-772-8126

Facility Contacts

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Kate Randolph, BS

Role: primary

[email protected]
409-223-7891

Other Identifiers

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23-0289

Identifier Type: -

Identifier Source: org_study_id