Recruiting

Observational Study

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT06098404

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Cancer

Study ID

NCT06098404

Start date

Mar 4, 2024

Status verified date

Dec, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Cancer Patients

Patients diagnosed with cancer undergoing standard of care treatment.

Primary outcome measure

  • Characterization of fecal microbiome using molecular methods at baseline [ Time Frame: Baseline ]
  • Characterization of fecal microbiome using molecular methods at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Kate Randolph, BS

409-223-7891kmrandol@utmb.edu

Kristen McGovern, PhD

409-772-8126kamcgove@utmb.edu

Locations

The University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Kate Randolph, BS

409-223-7891kmrandol@utmb.edu

Principal Investigator:

Melinda Sheffield-Moore, PhD

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • Microbiome
  • Fatigue
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2025-12-16.